Lidocaine Pain Relieving Patch

Lidocaine Pain Relieving Patch
SPL v1
SPL
SPL Set ID 9b916733-4b34-427c-81e6-a62c70fa51a4
Route
TOPICAL
Published
Effective Date 2022-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (344 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Kaolin Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Povidone, Unspecified Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-02-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves minor pain.

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Topical anesthetic

Warnings

For external use only

Directions
  • Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use
  • Children 12 years of age or younger: Consult a physician.
Do Not Use
  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened.
Active Ingredient

Lidocaine 4.0%

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments

Call 1-888-287-1915

When Using This Product
  • Use only as directed
  • Read and follow all directions and warnings on this pack
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • 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
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
Principal Display Panel 1 Patch Pouch Label

NDC: 71391-150-01

LIDOCAINE

PAIN

RELIEVING

PATCH

LIDOCAINE 4% / Topical Anesthetic

Temporarily relieves pain

Stay-Put flexible Patch

Easy to apply & remove

No-mess, single use application

Odor-free

Lasts upto 12 hours

1 PATCH

3.93 X 5.5 IN

(10cm X 14cm)


Structured Label Content

Uses

Temporarily relieves minor pain.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Topical anesthetic

Warnings

For external use only

Directions
  • Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use
  • Children 12 years of age or younger: Consult a physician.
Do Not Use (Do not use)
  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened.
Active Ingredient

Lidocaine 4.0%

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments (Questions or Comments)

Call 1-888-287-1915

When Using This Product (When using this product)
  • Use only as directed
  • Read and follow all directions and warnings on this pack
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • 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
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
Principal Display Panel 1 Patch Pouch Label (PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label)

NDC: 71391-150-01

LIDOCAINE

PAIN

RELIEVING

PATCH

LIDOCAINE 4% / Topical Anesthetic

Temporarily relieves pain

Stay-Put flexible Patch

Easy to apply & remove

No-mess, single use application

Odor-free

Lasts upto 12 hours

1 PATCH

3.93 X 5.5 IN

(10cm X 14cm)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)