2 in 1 anti-Dandruff by Spa Dent Inc / Apollo Health and Beauty Care Drug Facts

2 in 1 anti-Dandruff by

Drug Labeling and Warnings

2 in 1 anti-Dandruff by is a Otc medication manufactured, distributed, or labeled by Spa Dent Inc, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

2 IN 1 ANTI-DANDRUFF- pyrithione zinc shampoo 
Spa Dent 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 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 right away.

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 (Cl 42090), Red 33 (Cl 17200).

PDP04

2 IN 1 ANTI-DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-027
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURETH-4 (UNII: 6HQ855798J)
DIMETHICONE (UNII: 92RU3N3Y1O)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-027-04	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/20/2021

Labeler - Spa Dent Inc (203478896)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Spa Dent Inc		203478896	manufacture(79147-027)

Revised: 7/2021

Document Id: e858b7b8-a977-430b-b19b-43db70bc9823

34390-5

Set id: 0ab1010e-169d-47fc-a5e5-6389ba13b10e

Version: 1

Effective Time: 20210727

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