85248-032

85248-032
SPL v1
SPL
SPL Set ID 49976ff7-49a4-e4ed-e063-6294a90a3f78
Route
TOPICAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Soybean Lecithin Water Carbomer 934 Benzyl Alcohol .alpha.-tocopherol Acetate Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30
Description

Lidocaine 4%(W/W)

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Lidocaine 4%(W/W)

Use

·Temporarily relieves pain and itching due to: minor burns,sunburn, insect bites, scrapes, minor skin irritations

Stop Use

·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptom being treated does not subside or if redness,iritation

Warnings

For external use only.

Ask Doctor

·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptom being treated does not subside or if redness,iritation

Directions

·Cleanse targeted skin area, pat dry. ·Apply a thin layer to the affected area, not more than 3-4 times daily.

Do Not Use

·on large areas of the body.·on broken, blistered, or abraded skin. · if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives

When Using

·avoid contact with the eyes - ·do not bandage tightly or use with heating pad -· use only as directed

Active Ingredient

Lidocaine 4%(W/W)

Other Information

Store at 15-30°C(59-86°F)·Protect from excessive heat and direct sunlight-· Use only as directed

Inactive Ingredients

Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Principal Display Panel

Keep Oot of Reach of Children

lf swallowed, get medical help or contact a poison control center right away.

Structured Label Content

Use

·Temporarily relieves pain and itching due to: minor burns,sunburn, insect bites, scrapes, minor skin irritations

Purpose

External analgesic

Stop Use

·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptom being treated does not subside or if redness,iritation

Warnings

For external use only.

Ask Doctor

·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptom being treated does not subside or if redness,iritation

Directions

·Cleanse targeted skin area, pat dry. ·Apply a thin layer to the affected area, not more than 3-4 times daily.

Do Not Use (Do not use)

·on large areas of the body.·on broken, blistered, or abraded skin. · if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives

When Using

·avoid contact with the eyes - ·do not bandage tightly or use with heating pad -· use only as directed

Active Ingredient

Lidocaine 4%(W/W)

Other Information (Other information)

Store at 15-30°C(59-86°F)·Protect from excessive heat and direct sunlight-· Use only as directed

Inactive Ingredients (Inactive ingredients)

Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

lf swallowed, get medical help or contact a poison control center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.903544 · Updated: 2026-03-14T23:12:42.073607