SKIN BEAUTIFYING MILK- hydroquinone cream

Skin Beautifying Milk by

Drug Labeling and Warnings

Skin Beautifying Milk by is a Otc medication manufactured, distributed, or labeled by Bluefield Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

Active Ingredient

Hydroquinone 2.0%

Purpose

Skin Lightener

Uses:

• For an even toned glow by fading away skin discolorations such as age spots, freckles, or dark patches that may occur from pregnancy or the use of birth control pills.

Warnings

For External use only.

WHEN USING THIS PRODUCT

• Avoid contact with eyes.
• Avoid unnecessary sun exposure and use a sunscreen to prevent darkening from reoccuring.
• Test overnight on Inside of elbow before use.
• If skin irritation occurs, discontinue use and consult a doctor.

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

• Spread a thin layer into patches on face, hands, arms or body..
  
• Use twice daily or as directed by a doctor and in 4-6 weeks the effect should be evident.
  
• Not for use on children under 12 except on doctor's intructions.

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).

INGREDIENTS AND APPEARANCE

SKIN BEAUTIFYING MILK 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16708-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16708-001-01	1 in 1 BOX
1		227 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	10/27/2015

Labeler - Bluefield Associates, Inc. (626594667)

Establishment
Name	Address	ID/FEI	Business Operations
Bluefield Associates, Inc.		626594667	manufacture(16708-001)