Signature Numbing Cream 30g/ 1.0 Oz

Signature Numbing Cream 30g/ 1.0 Oz
SPL v1
SPL
SPL Set ID 3e1892de-378b-d2d0-e063-6294a90ad7db
Route
RECTAL
Published
Effective Date 2025-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-06

Description

For external use only


Medication Information

Warnings and Precautions

For external use only

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.

Dosage and Administration

Apply 1-3 times a week

Description

For external use only

Section 50566-9

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

Section 50567-7

Wash the area with soap and water

Section 51727-6

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

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

Section 51945-4

Section 55105-1

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

Section 55106-9

5% Lidocaine


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

Warnings and Precautions (34071-1)

For external use only

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

Wash the area with soap and water

Section 51727-6 (51727-6)

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

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

5% Lidocaine


Advanced Ingredient Data


Raw Label Data

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