UREA by Shenzhen Xiaomai Manufacturing Co., Ltd. UREA- cream cream

UREA by

Drug Labeling and Warnings

UREA by is a Otc medication manufactured, distributed, or labeled by Shenzhen Xiaomai Manufacturing Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Urea 40%

Salicylic Acid 2%

Purpose

Anti-wrinkle, moisturizes

Uses

Anti-wrinkle, moisturizes, nourishes and repairs skin, keeping skin hydrated, soft and smooth.

Warnings

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

Do not use

Do not use on damaged or broken skin

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

Ask Doctor

When Pregnant or breast-feeding.

Directions

1. After cleansing the face, take an appropriate amount of spot lightening cream.
2. Apply evenly to the area on the face that needs to lighten spots, and massage gently until completely absorbed.
3. Use once in the morning and evening. Continuous use will provide better results.

Other information

Please store in a cool, dry place away from direct sunlight.

Inactive ingredients

Water,Camellia Sinensis Leaf Extract,CocosNucifera (Coconut) Oil,Dodecane, Cetearyl Alcohol, Polysorbate60,Glyceryl Stearate, PEG-100 stearate,CetylAlcohol, AloeBarbadensis LeafJuice,Melaleuca Alternifolia (Tea Tree)LeafOil,Glycerin,Dipropylene Glycol, Carbomer,Xanthan Gum,Ethythexylglycerin,Caprylyl Glycol, Butyrospermum Parkii(Shea) oil,Hexylene Glycol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREA 
cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83872-358
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
(HYDROXYMETHYL)UREA (UNII: 15BY095DMS) ((HYDROXYMETHYL)UREA - UNII:15BY095DMS)	(HYDROXYMETHYL)UREA	20 g  in 50 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-60 GLYCERYL STEARATE (UNII: 85O35YN6YY)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
DODECANE (UNII: 11A386X1QH)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83872-358-01	50 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	07/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/24/2024

Labeler - Shenzhen Xiaomai Manufacturing Co., Ltd. (712999147)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Xiaomai Manufacturing Co., Ltd.		712999147	manufacture(83872-358)