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P.O.V. Classic Dandruff by Apollo Health and Beauty Care Inc.

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 10mg in 1mL
Labeler: Apollo Health and Beauty Care Inc.
NDC Code: 63148-411

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.

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

Questions or comments?

1-866-695-3030

Label Copy

P.O.V. CLASSIC DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-411
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
SODIUM CHLORIDE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
GLYCOL DISTEARATE 
COCAMIDOPROPYL BETAINE 
COCO MONOETHANOLAMIDE 
LAURETH-4 
SODIUM HYDROXIDE 
EDETATE SODIUM 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C BLUE NO. 1 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:63148-411-24701 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/26/2017
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIOperations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-411)

Revised: 12/2017
 
Apollo Health and Beauty Care Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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