Signature Numbing Cream 10g/0.35 Oz

Signature Numbing Cream 10g/0.35 Oz
SPL v1
SPL
SPL Set ID 3d3b771f-5e30-b23e-e063-6294a90a3fb2
Route
RECTAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (100 mg)
Inactive Ingredients
Carbomer 934 Lecithin, Soybean Benzyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-26

Description

For external use only

Purpose

Temporary relief of pain, itching, soreness, or burning in the perianal area from anorectal disorders.


Medication Information

Indications and Usage

Adults and children 12 years and older: When practical, cleanse the affected area with mild soap andwarm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft clothbefore application of this product.Apply to the affected area up to 6 times daily.Children under 12 years: Consult a doctor.

Purpose

Temporary relief of pain, itching, soreness, or burning in the perianal area from anorectal disorders.

Dosage and Administration

Apply 1-3 times a week

Description

For external use only

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51945-4

Stop Use

Allergic reaction or rectal bleeding occurs.Redness,irritation, swelling, or pain increases.Condition worsens or lasts >7 days

Warnings

For external use only

When Using

Wash the area with soap and water.

Active Ingredient

5% Lidocaine

Inactive Ingredient

Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Mentha Arvensis Leaf Extract, Chrysanthemum Indicum

Extract, Portulaca Oleracea Extract, Propylene Glycol, Tocopheryl Acetate, Water


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years and older: When practical, cleanse the affected area with mild soap andwarm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft clothbefore application of this product.Apply to the affected area up to 6 times daily.Children under 12 years: Consult a doctor.

Dosage and Administration (34068-7)

Apply 1-3 times a week

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Temporary relief of pain, itching, soreness, or burning in the perianal area from anorectal disorders.

Stop Use (STOP USE)

Allergic reaction or rectal bleeding occurs.Redness,irritation, swelling, or pain increases.Condition worsens or lasts >7 days

Warnings (WARNINGS)

For external use only

When Using (WHEN USING)

Wash the area with soap and water.

Active Ingredient (ACTIVE INGREDIENT)

5% Lidocaine

Inactive Ingredient (INACTIVE INGREDIENT)

Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Mentha Arvensis Leaf Extract, Chrysanthemum Indicum

Extract, Portulaca Oleracea Extract, Propylene Glycol, Tocopheryl Acetate, Water


Advanced Ingredient Data


Raw Label Data

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