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
Purpose

External analgesic

Description

Lidocaine 4%(W/W)

Medication Information

Warnings

For external use only.

Purpose

External analgesic

Directions

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

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.

Description

Lidocaine 4%(W/W)

Principal Display Panel

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

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

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)

Keep Oot of Reach of Children

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

Structured Label Content

Warnings

For external use only.

Purpose

External analgesic

Directions

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

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)

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

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

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)

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