DR WELLSKIN NUMBING CREAM- 5% lidocaine cream

Dr Wellskin Numbing Cream by

Drug Labeling and Warnings

Dr Wellskin Numbing Cream by is a Otc medication manufactured, distributed, or labeled by Shengnan (Guangzhou) Cosmetics Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

For external use only.

PURPOSE

Anorectal
(Hemorrhoidal)

STOP USE

Allergic reaction occurs.
Rectal bleeding occurs.
Condition worsens or does not improve within 7 days.
Redness, irritation, sweling, pain, or other symptoms begin or increase.

ACTIVE INGREDIENT

5% Lidocaine

WHEN USING

Do not exceed the recommended daily dosage unless directed by adoctor
Do not insert into the rectum using fingers or any mechanical device orapplicator

INACTIVE INGREDIENT

Water, Propylene Glycol, Glycerin, Carbomer, Disodium EDTA, Hydroxyacetophenone, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Mentha Arvensis Leaf Extract, Chrysanthellum Indicum Extract, Portulaca Oleracea Extract,Tocopheryl Acetate.

DOSAGE & ADMINISTRATION

Adults and children 12
years and older: Apply a
thin layer to the affected
area 1-3 times daily or
as directed by a
healthcare provider.

INDICATIONS & USAGE

Adults and children 12 years and older: When practical, cleanse theaffected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
Apply a thin layer of cream to the affected area up to 6 times daily as needed.
Children under 12 years: Consult a doctor.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right
away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR WELLSKIN NUMBING CREAM 
5% lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84019-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CARBOMER (UNII: 0A5MM307FC)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84019-040-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/09/2026

Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)

Establishment
Name	Address	ID/FEI	Business Operations
Shengnan (Guangzhou) Cosmetics Co., LTD		541200425	manufacture(84019-040)