Urea 12% Cream by Guangzhou Yanxi Biotechnology Co., Ltd UREA 12% CREAM cream

Urea 12% Cream by

Drug Labeling and Warnings

Urea 12% Cream by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yanxi Biotechnology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

use as a normal foot cream

WARNINGS

keep out of children

INACTIVE INGREDIENT

Aqua

INDICATIONS & USAGE

for foot care

KEEP OUT OF REACH OF CHILDREN

keep out of children

PURPOSE

moisturize feet

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREA 12% CREAM 
urea 12% cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84025-091
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	5 mg  in 100 mL
PEG-100 STEARATE (UNII: YD01N1999R) (PEG-100 STEARATE - UNII:YD01N1999R)	PEG-100 STEARATE	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84025-091-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/26/2024

Labeler - Guangzhou Yanxi Biotechnology Co., Ltd (632583102)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yanxi Biotechnology Co., Ltd		632583102	manufacture(84025-091)