Signature Numb Cream 10g/0.35 Oz

Signature Numb Cream 10g/0.35 Oz
SPL v1
SPL
SPL Set ID 3d2ecb86-6bb1-2528-e063-6394a90a8d89
Route
CUTANEOUS
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-25

Description

Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children.


Medication Information

Warnings and Precautions

Stop use and consulta doctor if an allergicreaction occurs.

Keep out of reach of children.

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

Stop use and consulta doctor if an allergicreaction occurs. Keep out of reach of children.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

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

Used for numbing local area prior to tattooing

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)

Stop use and consulta doctor if an allergicreaction occurs.

Keep out of reach of children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

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)

Used for numbing local area prior to tattooing

Section 55106-9 (55106-9)

5% Lidocaine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)