TOPCO ASSOCIATES- selenium sulfide shampoo

Topco Associates by

Drug Labeling and Warnings

Topco Associates by is a Otc medication manufactured, distributed, or labeled by Topco Associates, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Selenium Sulfide 1%

PURPOSE

anti dandruff

WARNINGS

For external use only.

Ask a doctor before useif 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 ifcondition 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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

store at room temperature.

INACTIVE INGREDIENT

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).

QUESTIONS

1-888-423-0139

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCO ASSOCIATES 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MENTHOL (UNII: L7T10EIP3A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-171-11	325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	05/04/2023

Labeler - Topco Associates (006935977)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(76162-171)