SPL v2
SPL
SPL Set ID 39744127-ab37-0617-e063-6294a90a23af
Route
TOPICAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Benzyl Alcohol Stearyl Alcohol Sodium Hydroxide Propylene Glycol Cetyl Alcohol Carbomer 1342 Water Glycerin

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-08

Description

Topical anesthetic

Purpose

Topical anesthetic

Dosage and Administration

Adults and children 12 years and older: • Apply a thin layer to affected area not more than 3 to 4 times daily. Children under 12 years: • Consult a doctor before use.


Medication Information

Purpose

Topical anesthetic

Dosage and Administration

Adults and children 12 years and older:

• Apply a thin layer to affected area not more than 3 to 4 times daily.

Children under 12 years:

• Consult a doctor before use.

Description

Topical anesthetic

Uses

Temporarily relieves pain and itching due to minor cuts, scrapes, burns, insect bites, and skin irritations.

Warnings

For external use only.

Avoid contact with eyes.

Do not use:

• on large areas of the body

• on broken or blistered skin

• for more than 7 days unless directed by a doctor

Stop use and ask a doctor if:

• condition worsens

• symptoms persist for more than 7 days or clear up and occur again within a few days

• redness, irritation, swelling, or pain persists or increases

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Purified Water, Propylene Glycol, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Carbomer 1342, Benzyl Alcohol, Sodium Hydroxide.

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.

Black Cobra 4% Lidocaine Numbing Cream – Principal Display Panel

See image below.


Structured Label Content

Uses

Temporarily relieves pain and itching due to minor cuts, scrapes, burns, insect bites, and skin irritations.

Purpose

Topical anesthetic

Warnings

For external use only.

Avoid contact with eyes.

Do not use:

• on large areas of the body

• on broken or blistered skin

• for more than 7 days unless directed by a doctor

Stop use and ask a doctor if:

• condition worsens

• symptoms persist for more than 7 days or clear up and occur again within a few days

• redness, irritation, swelling, or pain persists or increases

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Purified Water, Propylene Glycol, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Carbomer 1342, Benzyl Alcohol, Sodium Hydroxide.

Dosage and Administration

Adults and children 12 years and older:

• Apply a thin layer to affected area not more than 3 to 4 times daily.

Children under 12 years:

• Consult a doctor before use.

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.

Black Cobra 4% Lidocaine Numbing Cream – Principal Display Panel

See image below.


Advanced Ingredient Data


Raw Label Data

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