TOPCO ASSOCIATES- selenium sulfide shampoo 
Topco Associates

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.

----------

Topcare Medicated Shampoo-76162-171-11

Selenium Sulfide 1%

anti dandruff

For external use only.

Ask a doctor before use if you have seborrheic dermatitis in areas other than the scalp.

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

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

■ shake well, wet hair, massage onto scalp and rinse.
■ for best results, use at least twice a week or as directed by a doctor.

store at room temperature.

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid,
Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose,
Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

1-888-423-0139

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

11 oz

TOPCO ASSOCIATES 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
WATER (UNII: 059QF0KO0R)  
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)  
HYDROXYPROPYL METHACRYLATE (UNII: UKW89XAX2X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-171-11325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03205/04/2023
Labeler - Topco Associates (006935977)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(76162-171)

Revised: 5/2023
Document Id: fadf4e81-eac3-e407-e053-6394a90a4932
Set id: ecf87660-f552-1f6b-e053-2a95a90a2486
Version: 2
Effective Time: 20230504
 
Topco Associates