SPL v1
SPL
SPL Set ID 38715ce6-d072-dfe5-e063-6394a90a24f0
Route
TOPICAL
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Glycerin Alpha-tocopherol Acetate Carbomer Sodium Hydroxide Phenoxyethanol Propylene Glycol Allantoin Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-25
Description

Lidocaine 4% ---Topical anesthetic

Purpose

Local anesthetic

Medication Information

Purpose

Local anesthetic

Description

Lidocaine 4% ---Topical anesthetic

Uses

Temporarily helps reduce discomfort from:

Minor burns,Insect bites,Minor skin,irritations,Post-shaving or grooming sensitivity.

External itching or rash due to dry skin.

Warnings

For external use only

Do not use on large areas of the body or on broken, blistered, or abraded skin.

Avoid contact with eyes, mouth, and mucous membranes.

If pregnant or breastfeeding, consult a healthcare provider before use.

Directions

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Active Ingredient

Lidocaine 4% ---Topical anesthetic

Other Information

Store at room temperature (15–30°C / 59–86°F) Tamper evident: Do not use if seal is broken or missing.

Inactive Ingredients

Purified Water, Glycerin, Allantoin,Tocopheryl Acetate (Vitamin E),Carbomer, Propylene Glycol,Sodium Hydroxide, Phenoxyethanol,

Ethylhexylglycerin

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If:

Condition worsens or symptomspersist for more than 7 days.

Skin irritation, rash, or allergic reaction occurs.

Structured Label Content

Uses (USES)

Temporarily helps reduce discomfort from:

Minor burns,Insect bites,Minor skin,irritations,Post-shaving or grooming sensitivity.

External itching or rash due to dry skin.

Purpose (PURPOSE)

Local anesthetic

Warnings (WARNINGS)

For external use only

Do not use on large areas of the body or on broken, blistered, or abraded skin.

Avoid contact with eyes, mouth, and mucous membranes.

If pregnant or breastfeeding, consult a healthcare provider before use.

Directions (DIRECTIONS)

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Active Ingredient (ACTIVE INGREDIENT)

Lidocaine 4% ---Topical anesthetic

Other Information (OTHER INFORMATION)

Store at room temperature (15–30°C / 59–86°F) Tamper evident: Do not use if seal is broken or missing.

Inactive Ingredients (INACTIVE INGREDIENTS)

Purified Water, Glycerin, Allantoin,Tocopheryl Acetate (Vitamin E),Carbomer, Propylene Glycol,Sodium Hydroxide, Phenoxyethanol,

Ethylhexylglycerin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Condition worsens or symptomspersist for more than 7 days.

Skin irritation, rash, or allergic reaction occurs.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:23.655914 · Updated: 2026-03-14T23:09:09.169888