SKIN BEAUTIFYING MILK- hydroquinone cream 
Bluefield Associates, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Skin Beautifying Milk

PRINCIPAL DISPLAY PANEL

SkinMilk

Active Ingredient

Hydroquinone 2.0%

Purpose

Skin Lightener

Uses:

Warnings

For External use only.

WHEN USING THIS PRODUCT

Do Not use on

children under 12 years of age unless directed by a doctor.

Keep out of the reach of children.

If swallowed, seek medical assistance.

Questions or Comments?

1-800-423-0306 or sales@bluefieldInc.com

Directions

OTHER INFORMATION

Close lid tightly after each use. Product may darken when exposed to air. This will not affect performance or safety.

Inactive Ingredients

Water (Aqua), White Petrolatum, Cetyl Alcohol, Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Stearic Acid, Ammonium Lauryl Sulfate, Dimethicone, Diazolidinyl Urea, Methylparaben, Propylparaben, Glyceryl Stearate,Sodium Metabisulfite, Ascorbic Acid, BHA, Propul Gallate,Trisodium EDTA, Fragrance (Parfum).

SKIN BEAUTIFYING MILK 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16708-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16708-001-011 in 1 BOX
1227 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A10/27/2015
Labeler - Bluefield Associates, Inc. (626594667)
Establishment
NameAddressID/FEIBusiness Operations
Bluefield Associates, Inc.626594667manufacture(16708-001)

Revised: 10/2015
Document Id: 23e46dbd-61b3-0bd1-e054-00144ff88e88
Set id: 23e46dbd-61b2-0bd1-e054-00144ff88e88
Version: 1
Effective Time: 20151028
 
Bluefield Associates, Inc.