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

Purpose

Topical Analgesic

Description

Lidocaine HCl 3%


Medication Information

Warnings

• For External Use Only

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.

Purpose

Topical Analgesic

Other Information

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

Description

Lidocaine HCl 3%

Section 50565-1

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

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%

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

Warnings

• For External Use Only

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.

Purpose

Topical Analgesic

Other Information (Other information)

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

Section 50565-1 (50565-1)

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

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%

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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