SPL v1
SPL
SPL Set ID 3557859e-f8b3-1049-e063-6394a90ad737
Route
TOPICAL
Published
Effective Date 2025-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Propylene Glycol Chrysanthellum Indicum Top Aqua Mentha Arvensis Leaf Purslane 1,2-hexanediol Tetracaine Peg-40 Hydrogenated Castor Oil Edetate Disodium Prilocaine Carbomer Glycerin Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-17

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

Warnings:For external use onlyAvoid contact with the eyes.Do not use in large quantities, particularly over raw surfaces or blistered areas anddo not exceed the recommended daily dosage unless directed by a doctor.

Indications and Usage

Directions:

Children under 12 years of age: Consult a physician.

Dosage and Administration

Adults:1. When practical, cleanse the affected area with mild soap and warmwater and rinse thoroughly. Gently dry it by patting or blotting it withtoilet tissue or a soft cloth before applying this product.

2. Apply a thin layer to the affected area every 6 to 8 hours, not toexceed 3 applications in a 24-hour period.

Description

Lidocaine 4%

Section 50565-1

Children under 12 years of age: Consult a physician. keep out of reach of children

Section 50566-9

Stop use and ask a doctor if

lf symptoms of redness or allergy occur, discontinue use, and consult a physician.

Section 50567-7

When using this productAvoid contact with eyes. In case of accidental contact, rinse eyes with a largeamount of cool tap water.

Section 50569-3

Ask a doctor before use if you havelf pregnant or breast-feeding, ask a health professional before use.

Section 51727-6

Inactive ingredientS:TETRACAINE PRILOCAINE AQUA PROPYLENEGLYCOL CARBOMER GLYCERIN DISODIUM EDTA HYDROXYACETOPHENONE1,2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT CHRYSANTHELLUMINDICUM EXTRACT PORTULACA OLERACEA EXTRACT PEG-40HYDROGENATED CASTOR OIL

Section 51945-4

Section 55105-1

Uses:For the temporary relief of local and anorectal itching and discomfortassociated with anorectal disorders.

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Directions:

Children under 12 years of age: Consult a physician.

Dosage and Administration (34068-7)

Adults:1. When practical, cleanse the affected area with mild soap and warmwater and rinse thoroughly. Gently dry it by patting or blotting it withtoilet tissue or a soft cloth before applying this product.

2. Apply a thin layer to the affected area every 6 to 8 hours, not toexceed 3 applications in a 24-hour period.

Warnings and Precautions (34071-1)

Warnings:For external use onlyAvoid contact with the eyes.Do not use in large quantities, particularly over raw surfaces or blistered areas anddo not exceed the recommended daily dosage unless directed by a doctor.

Section 50565-1 (50565-1)

Children under 12 years of age: Consult a physician. keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if

lf symptoms of redness or allergy occur, discontinue use, and consult a physician.

Section 50567-7 (50567-7)

When using this productAvoid contact with eyes. In case of accidental contact, rinse eyes with a largeamount of cool tap water.

Section 50569-3 (50569-3)

Ask a doctor before use if you havelf pregnant or breast-feeding, ask a health professional before use.

Section 51727-6 (51727-6)

Inactive ingredientS:TETRACAINE PRILOCAINE AQUA PROPYLENEGLYCOL CARBOMER GLYCERIN DISODIUM EDTA HYDROXYACETOPHENONE1,2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT CHRYSANTHELLUMINDICUM EXTRACT PORTULACA OLERACEA EXTRACT PEG-40HYDROGENATED CASTOR OIL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses:For the temporary relief of local and anorectal itching and discomfortassociated with anorectal disorders.

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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