P.O.V. Green Apple 2 in 1 Dandruff: Package Insert and Label Information

P.O.V. GREEN APPLE 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.

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, Cocamide MEA, Glycol Distearate, Dimethicone, Acrylates Copolymer, Cocamidopropyl Betaine, Fragrance (Parfum), Laureth-4, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Questions or comments?

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Label Copy

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P.O.V. GREEN APPLE 2 IN 1 DANDRUFF
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-431
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURETH SULFATE
SODIUM CHLORIDE
COCO MONOETHANOLAMIDE
GLYCOL DISTEARATE
DIMETHICONE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
COCAMIDOPROPYL BETAINE
LAURETH-4
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
SODIUM HYDROXIDE
EDETATE SODIUM
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63148-431-14 399 mL in 1 BOTTLE, PLASTIC None
2 NDC:63148-431-24 701 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 11/20/2017
Labeler — Apollo Health and Beauty Care Inc. (201901209)
Registrant — Apollo Health and Beauty Care Inc. (201901209)
Establishment
Name Address ID/FEI Operations
Apollo Health and Beauty Care Inc. 201901209 manufacture (63148-431)

Revised: 11/2017 Apollo Health and Beauty Care Inc.

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