OTHINE SKIN BLEACH- hydroquinone, octisalate cream

Othine Skin Bleach by

Drug Labeling and Warnings

Othine 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, 3%; Octisalate, 3%

Purpose

Skin Lightener

Sunscreen

Uses:

Gradually fades areas of skin discoloration 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 inflamed or broken skin 
• to prevent sunburn 
• 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 consukt a doctor if

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

If pregnant or breast-feeding

consult a health professional before use.

Keep out of reach of children

consult a health professional before use.

Directions:

• If skin is sensitive, test on a small area inside elbow overnight before use. 
• Adults and children 12 years and older, apply as a thin layer to affected area twice daily, or as directed by a doctor.
• If going outside, use a sunscreen or wear protective clothing
• Children under 12 years of age, ask a doctor before use.

Inactive Ingredients:

water, mineral oil, stearyl alcohol, decyl oleate, glyceryl stearate, oleth-20, laureth-23, propylene glycol, stearamidopropyl dimethylamine, citric acid, sodium metabisulfite, methylparaben, propylparaben, fragrance

Package Labeling

INGREDIENTS AND APPEARANCE

OTHINE SKIN BLEACH 
hydroquinone, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12022-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DECYL OLEATE (UNII: ZGR06DO97T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OLETH-20 (UNII: YTH167I2AG)
LAURETH-23 (UNII: N72LMW566G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12022-016-00	1 in 1 CARTON	07/01/1974
1		64 g in 1 JAR; 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	07/01/1974

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Establishment
Name	Address	ID/FEI	Business Operations
J. Strickland & Co.		007023112	manufacture(12022-016) , pack(12022-016) , label(12022-016)