BLACK AND WHITE SKIN BLEACH- hydroquinone cream

Black and White Skin Bleach by

Drug Labeling and Warnings

Black and White Skin Bleach by is a Otc medication manufactured, distributed, or labeled by J. Strickland & Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Hydroquinone, 2%

Purpose

Skin Lightener

Uses:

Gradually fades skin discolorations such as

• age spots
• freckles
• liver spots
• dark areas that can occur while using oral contraceptives

Warnings:

For External Use Only.

Do not use on

• on inflamed or broken skin
• if product is tan or brown

When using this product

• mild irritation may occur
• avoid contact with eyes. If contact occurs, rinse with water.
• avoid unnecessary sun exposure and use a sunscreen or protective clothing

Stop use and consult a doctor if

• a gradual blue-black darkening of the skin occurs
• if irritation becomes severe
• if no improvement is seen after 3 months

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children

Directions:

• If skin is sensitive, test on a small area inside the elbow overnight before use.
• Adults and children 12 years and older: apply as a thin layer to affected area twice daily
• Children under 12 years of age: ask a doctor before use.

Inactive Ingredients:

water, glyceryl stearate. PEG-8, cetyl esters, mineral oil, cetyl alcohol, sodium sulfite, ascorbic acid, citric acid, methylparaben, fragrance.

Package Labeling

Package Labeling

INGREDIENTS AND APPEARANCE

BLACK AND WHITE SKIN BLEACH 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12022-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ESTERS WAX (UNII: D072FFP9GU)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM SULFITE (UNII: VTK01UQK3G)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12022-003-00	1 in 1 CARTON	12/01/1990
1		21 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 12022-003-01	1 in 1 CARTON	12/01/1990
2		43 g in 1 TUBE; 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	12/01/1990

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Establishment
Name	Address	ID/FEI	Business Operations
J. Strickland & Co.		007023112	manufacture(12022-003) , pack(12022-003) , label(12022-003)