BLACK AND WHITE SKIN BLEACH- hydroquinone cream
J. Strickland & Co.

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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Black & White Skin Bleach Cream

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

12022-003-00

Package Labeling

12022-003-01

BLACK AND WHITE SKIN BLEACH
hydroquinone cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-003-00	1 in 1 CARTON	12/01/1990	09/28/2020
1		21 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:12022-003-01	1 in 1 CARTON	12/01/1990	09/28/2020
2		43 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358A	12/01/1990	09/28/2020

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

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

Revised: 11/2020

Document Id: b34c8abf-9178-a27a-e053-2a95a90ac4a6

Set id: b303b837-fc01-4acd-a860-30555cf86c1f

Version: 2

Effective Time: 20201104

J. Strickland & Co.