Ndc 59088-241 Lidocaine 3% Cream

Ndc 59088-241 Lidocaine 3% Cream
SPL v1
SPL
SPL Set ID 3bc94d52-fe52-9fd6-e063-6294a90a4340
Route
TOPICAL
Published
Effective Date 2025-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Mineral Oil Cetearyl Alcohol Sodium Phosphate Propylene Glycol Glycerin Water Propylparaben Methylparaben Petrolatum Calcium Acetate Ceteareth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-12
Description

Lidocaine HCl 3%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Lidocaine HCl 3%

Uses

For the temporarily relief of pain and itching associated with:

•minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations •rashes due to poison ivy, poison oak, or poison sumac.

Section 50565-1

• Keep this and all other drugs out of the reach of children.

Warnings

• For External Use Only

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: do not use, consult a licensed healthcare practitioner.

Active Ingredient

Lidocaine HCl 3%

Other Information

• Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Lidocaine 3% Cream

Inactive Ingredients:

Aqua (Purified Water), Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Sodium Phosphate.

When Using This Product:

•Avoid contact with the eyes. •Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use and Ask A Doctor If

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a licensed healthcare practitioner.

Structured Label Content

Uses

For the temporarily relief of pain and itching associated with:

•minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations •rashes due to poison ivy, poison oak, or poison sumac.

Section 50565-1 (50565-1)

• Keep this and all other drugs out of the reach of children.

Purpose

Topical Analgesic

Warnings

• For External Use Only

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: do not use, consult a licensed healthcare practitioner.

Active Ingredient

Lidocaine HCl 3%

Other Information (Other information)

• Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Lidocaine 3% Cream

Inactive Ingredients: (Inactive ingredients:)

Aqua (Purified Water), Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Sodium Phosphate.

When Using This Product: (When using this product:)

•Avoid contact with the eyes. •Do not use in large quantities, particularly over raw surfaces or blistered areas.

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

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a licensed healthcare practitioner.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:44.517930 · Updated: 2026-03-14T23:09:41.311223