2 In 1 Antidandruff (Pyrithione Zinc) Shampoo [Apollo Health And Beauty Care Inc.] -

2 IN 1 ANTIDANDRUFF (PYRITHIONE ZINC) SHAMPOO [APOLLO HEALTH AND BEAUTY CARE INC.]
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NDC	63148-415-14
Set ID	b368195a-9485-4d29-906f-7710139e55de
Category	HUMAN OTC DRUG LABEL
Packager	Apollo Health and Beauty Care Inc.
Generic Name
Product Class
Product Number
Application Number	PART358H

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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 eyes 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.

If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- For best results, use at least twice a week or as directed by a doctor.
- For maximum dandruff control, use every time you shampoo.
- Wet hair, massage onto scalp and rinse. Repeat if desired.
Other information

Store at room temperature.
Inactive ingredients

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

INGREDIENTS AND APPEARANCE

2 IN 1 ANTIDANDRUFF
pyrithione zinc shampoo

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63148-415-14	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/29/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/29/2017

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-415)

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