UreaCream by Shengnan (Guangzhou) Cosmetics Co., LTD / Shengnan (Guangzhou) Cosmetics Co., Ltd UREACREAM- urea cream

UreaCream by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS

For externnl use only.Avoid direct contact with eyes

PURPOSE

Improves the texture of foot akin, reduicing roughness and making it smoother and more refined.

USE SECTION

Stop use and ask doctor if rash occurs.

ACTIVE INGREDIENT

Urea 40%

WHEN USING SECTION

Do not apply to wounds or damaged skin

INACTIVE INGREDIENT

Water
Beeswax

Glycerin

Salicylic Acid

Butyrospermum Parkii （Shea） Butter
Dimethicone

Caprylic/Capric Triglyceride
Cetearyl Alcohol

Propylene Glycol
Fragrance
Phenoxyethanol
Palmitic Acid

Stearic Acid
Tocopherol
Panthenol

DOSAGE & ADMINISTRATION

Apply 1-2 times a day

INDICATIONS & USAGE

Gently clean the slin let it dry.Apply cream to theafected area. Gendy massage until fullyabsorbed

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREACREAM 
urea cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84019-009
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA (UNII: 0214C2T14J) (1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA - UNII:0214C2T14J)	1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
FRAGRANCE 13576 (UNII: 5EM498GW35)
TOCOPHEROL (UNII: R0ZB2556P8)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BEESWAX (UNII: 2ZA36H0S2V)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84019-009-01	40 g in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/18/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Shengnan (Guangzhou) Cosmetics Co., Ltd		541200425	manufacture(84019-009)