SPL v2
SPL
SPL Set ID 019efef6-b8c0-59ec-e063-6294a90a3468
Route
TOPICAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Polyacrylic Acid (8000 Mw) Polysorbate 80 Propylene Glycol Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Urea Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-08-01
Description

Active Ingredient Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose Topical Anesthetic Uses for the temporary relief of pain Warnings For external use only Do not use more than 1 patch on your body at a time on puncture wounds, on cuts, irritated or swollen skin for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness or irritation develops you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). Directions Adults and children over 12 years: wish and dry affected area Peel off the backing fim from one side of the patch carefully Apply the exposed portion of the patch to the affected area Gently press the patch with your hand to fit the affected area completely Do not exercise vigorously during use to prevent the patch from falling off use only 1 patch for a maximum of 8 hours children under 12 years of age: Ask a doctor before use Other Information store at room temperature 15°-30°C (59°-86°F). Inactive ingredients aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water Questions or Comments? E-mail: [email protected] Child-Resistant Packaging Manufactured for CARE LIVING DIAGNOSTICS INC. Www.carelivingusa.com Made in China

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Description

Active Ingredient Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose Topical Anesthetic Uses for the temporary relief of pain Warnings For external use only Do not use more than 1 patch on your body at a time on puncture wounds, on cuts, irritated or swollen skin for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness or irritation develops you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). Directions Adults and children over 12 years: wish and dry affected area Peel off the backing fim from one side of the patch carefully Apply the exposed portion of the patch to the affected area Gently press the patch with your hand to fit the affected area completely Do not exercise vigorously during use to prevent the patch from falling off use only 1 patch for a maximum of 8 hours children under 12 years of age: Ask a doctor before use Other Information store at room temperature 15°-30°C (59°-86°F). Inactive ingredients aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water Questions or Comments? E-mail: [email protected] Child-Resistant Packaging Manufactured for CARE LIVING DIAGNOSTICS INC. Www.carelivingusa.com Made in China

Uses

for the temporary relief of pain

Dosage

0.246 g in 1 PATCH,5 PATCH in 1 CARTON

Section 51945-4

Warnings

For external use only

Directions

Adults and children 12 years of age and older:

  • Wash and dry the affected area.
  • Peel off the backing film from one side of the patch carefully.
  • Apply the exposed portion of the patch to the affected area.
  • Gently press the patch with your hand to fit the affected area completely.
  • Do not exercise vigorously during use to prevent the patch from falling off.
  • Ues only 1 patch for a maximum of 8 hours.

children under 12 years of age: Ask a doctor before use.

Do Not Use
  • more than 1 patch on your body at a time
  • on puncture wounds,
  • on cuts, irritated or swollen skin
  • for more than one week without consulting a doctor
Active Ingredient

Lidocaine 4%

Manufactured For:

CARE LIVING DIAGNOSTICSINC

www.carelivingusa.com

Made in China

Other Information

store at room temperature 15°-30°C (59°-86°F).

Product Information

Active Ingredient

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Purpose

Topical Anesthetic

Uses

for the temporary relief of pain

Warnings

For external use only

Do not use

  • more than 1 patch on your body at a time
  • on puncture wounds,
  • on cuts, irritated or swollen skin
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children over 12 years:

  • wish and dry affected area
  • Peel off the backing fim from one side of the patch carefully
  • Apply the exposed portion of the patch to the affected area
  • Gently press the patch with your hand to fit the affected area completely
  • Do not exercise vigorously during use to prevent the patch from falling off
  • use only 1 patch for a maximum of 8 hours

children under 12 years of age: Ask a doctor before use

Other Information

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water



Questions or Comments?

E-mail: [email protected]



Child-Resistant Packaging

Manufactured for

CARE LIVING DIAGNOSTICS INC.

Www.carelivingusa.com

Made in China

Inactive Ingredients

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water

Questions Or Comments?

E-mail:[email protected]

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets.
  • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or iritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering wherethe product was applied
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children and Pets.

lf swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222)

Structured Label Content

Uses

for the temporary relief of pain

Dosage

0.246 g in 1 PATCH,5 PATCH in 1 CARTON

Section 51945-4 (51945-4)

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and older:

  • Wash and dry the affected area.
  • Peel off the backing film from one side of the patch carefully.
  • Apply the exposed portion of the patch to the affected area.
  • Gently press the patch with your hand to fit the affected area completely.
  • Do not exercise vigorously during use to prevent the patch from falling off.
  • Ues only 1 patch for a maximum of 8 hours.

children under 12 years of age: Ask a doctor before use.

Do Not Use (Do not use)
  • more than 1 patch on your body at a time
  • on puncture wounds,
  • on cuts, irritated or swollen skin
  • for more than one week without consulting a doctor
Active Ingredient

Lidocaine 4%

Manufactured For: (Manufactured for:)

CARE LIVING DIAGNOSTICSINC

www.carelivingusa.com

Made in China

Other Information

store at room temperature 15°-30°C (59°-86°F).

Product Information

Active Ingredient

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Purpose

Topical Anesthetic

Uses

for the temporary relief of pain

Warnings

For external use only

Do not use

  • more than 1 patch on your body at a time
  • on puncture wounds,
  • on cuts, irritated or swollen skin
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children over 12 years:

  • wish and dry affected area
  • Peel off the backing fim from one side of the patch carefully
  • Apply the exposed portion of the patch to the affected area
  • Gently press the patch with your hand to fit the affected area completely
  • Do not exercise vigorously during use to prevent the patch from falling off
  • use only 1 patch for a maximum of 8 hours

children under 12 years of age: Ask a doctor before use

Other Information

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water



Questions or Comments?

E-mail: [email protected]



Child-Resistant Packaging

Manufactured for

CARE LIVING DIAGNOSTICS INC.

Www.carelivingusa.com

Made in China

Inactive Ingredients (Inactive ingredients)

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water

Questions Or Comments? (Questions or Comments?)

E-mail:[email protected]

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets.
  • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or iritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering wherethe product was applied
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

lf swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:06.850583 · Updated: 2026-03-14T23:01:15.754566