Healthwise Flexible 4% Lidocaine Patch

Healthwise Flexible 4% Lidocaine Patch
SPL v2
SPL
SPL Set ID 3869cc18-5494-6142-e063-6394a90a75e5
Route
TOPICAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Hydrogenated C6-20 Polyolefin (100 Cst) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/isoprene Copolymer (28:72; 210000 Mw) Propylene Glycol

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Lidocaine 4.0%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Lidocaine 4.0%

Use

Temporarily relief of pain.

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For External Use Only

Directions

Directions

■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period. Maximum 3 patches per day. Discard patch after single use.

■ Children under 2 years of age: Do not use, ask a doctor

Do Not Use

■over raw surfaces or blistered areas

Active Ingredient

Lidocaine 4.0%

Other Information

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

Inactive Ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, propylene glycol, styrene/isoprene copolymer

When Using This Product

■ Avoid contact with the eyes

■ Do not use more than one patch on your body at a time

Stop Use and Consult A Doctor If

■ skin Irritation develops

■ Condition worsens

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

Healthwise Flexible 4% Lidocaine Patch

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Use

Temporarily relief of pain.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

External analgesic

Warnings

For External Use Only

Directions

Directions

■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period. Maximum 3 patches per day. Discard patch after single use.

■ Children under 2 years of age: Do not use, ask a doctor

Do Not Use (Do not use)

■over raw surfaces or blistered areas

Active Ingredient

Lidocaine 4.0%

Other Information

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

Inactive Ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, propylene glycol, styrene/isoprene copolymer

When Using This Product (When using this product)

■ Avoid contact with the eyes

■ Do not use more than one patch on your body at a time

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

■ skin Irritation develops

■ Condition worsens

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

Healthwise Flexible 4% Lidocaine Patch (HealthWise Flexible 4% Lidocaine Patch)

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)