P.O.V. CLASSIC 2 IN 1 DANDRUFF- pyrithione zinc shampoo 
Apollo Health and Beauty Care Inc.

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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Drug Facts

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

to help prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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.

Directions

Wet hair and apply evenly to scalp, massaging gently. Rinse thoroughly. Repeat as needed. For best results, use at least twice a week or as directed by a doctor.

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Glycol Distearate, Cocamidopropyl Betaine, Acrylates Copolymer, Laureth-4, Dimethicone, Fragrance (Parfum), Cocamide MEA, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions or comments?

1-866-695-3030

Label Copy

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P.O.V. CLASSIC 2 IN 1 DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-441
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
LAURETH-4 (UNII: 6HQ855798J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-441-24701 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/24/2017
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-441)

Revised: 11/2017
Document Id: b05b5c58-3561-48fc-8e54-d93ad3b3c572
Set id: 61589d73-8e7e-4795-923b-347b125236e3
Version: 1
Effective Time: 20171127
 
Apollo Health and Beauty Care Inc.