Active Ingredient

Selenium Sulfide 1%

Purpose

Anti-Dandruff

Uses

Controls flaking, scaling and itching associated with dandruff

Warnings

For external use only

Do Not Use

On scalp that is broken or inflamed.
If you are allergic to ingredients in this product

When using this product

avoid contact with eyes. If contact occurs, rinse with water. For use on color treated or permed hair, rinse thoroughly

Stop using this product and ask doctor if

rash appears
condition worsens or does not improve in 2-4 weeks

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

If pregnant or breast feeding

ask a doctor before use

Directions

Adults and children 12 years and over: wet hair thoroughly, apply shampoo, generously lather, rinse thoroughly. Repeat. Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff.
Children under 12 years: ask a doctor

Other Information

store between 35o and 85o F (2o and 30oC)
protect from freezing
see bottom of bottle for lot number and expiration date

Inactive Ingredients

Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Dihydrogenated Tallow Phthalic Acid Amide, Cocamide DEA, Fragrance (Parfum), Titanium Dioxide, Dimethicone, Hydroxypropyl Methylcellulose, Citric Acid, Sodium Isostearoyl Lactylate, DMDM Hydantoin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Sodium Chloride, Blue 1 (CI 42090)

Package Front and Back Labels

ra11.jpg

CVS PHARMACY DANDRUFF MOISTURIZING WITH ALOE
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-611
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B)	SELENIUM SULFIDE	1 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-611-11	325 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	10/15/2010

Labeler - CVS Pharmacy Inc (062312574)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture