Pain Relief 4% Lidocaine Patch

Pain Relief 4% Lidocaine Patch
SPL v2
SPL
SPL Set ID bfee9be1-b265-44bd-8e82-2ec27132f82b
Route
TOPICAL
Published
Effective Date 2025-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-15

Description

Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

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.

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, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, methylparaben, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments

Call +91 9212228401

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 One Patch Pouch

NDC: 71391-151-01

PAIN RELIEF

4% LIDOCAINE PATCH

Desensitizes aggravated nerves

and relieves pain

No-mess

Single-use application

Easy to apply and remove

Stay-put flexible gel patch

Unscented

1 PATCH

3.93 X 5.51 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.

Purpose

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, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, methylparaben, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments (Questions or Comments)

Call +91 9212228401

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 One Patch Pouch (PRINCIPAL DISPLAY PANEL - One Patch Pouch)

NDC: 71391-151-01

PAIN RELIEF

4% LIDOCAINE PATCH

Desensitizes aggravated nerves

and relieves pain

No-mess

Single-use application

Easy to apply and remove

Stay-put flexible gel patch

Unscented

1 PATCH

3.93 X 5.51 IN

(10cm X 14cm)


Advanced Ingredient Data


Raw Label Data

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