DAMOAE THERAPY - pyrithione zinc shampoo 
DUALLIFE CO., LTD.

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

Inactive ingredients:

biotin, Dexpanthenol, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 80, MENTHA PIPERITA LEAF, CITRUS RETICULATA FRUIT OIL,
ALOE VERA LEAF, FALLOPIA MULTIFLORA ROOT, POLYQUATERNIUM-10 (400 CPS AT 2%), DIMETHICONE, ROSEMARY OIL, OENOTHERA BIENNIS FLOWERING TOP, LEVOMENTHOL,
1,2-HEXANEDIOL, CAPRYLYL GLYCOL, WATER

Purpose: Dandruff

Warnings:

If side-effects, such as redness, itching or swelling occur, discontinue use. If a irritation continues after discontinuing use, consult a dermatologist.
If a red area develops using this product or there is swelling or itchiness, consult a dermatologist.
Exposure to direct sunlight may cause side-effects as above.
Do not apply product to an area of skin that is affected by eczema or dermatitis.
Wash eyes immediately and thoroughly if product enters eyes.

Keep out of reach of children:

Replace the caps after use.
Keep away from babies and children.

Indication and usage:

Firstly, to wet hair root sufficiently with tepid water. Do pumping proper amount of shampoo, then simply do shampooing. Later, rinse it slightly.

Dosage and administration:

Do pumping enough amount of shampoo. Rub it with finger tip slowly as if you gave a massage for 3-5 minutes, and then rinse it sufficiently with tepid water.

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DAMOAE THERAPY 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76081-010
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE - UNII:6GK82EC25D) PYRITHIONE ZINC3 g  in 300 g
Inactive Ingredients
Ingredient NameStrength
biotin (UNII: 6SO6U10H04)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Dexpanthenol (UNII: 1O6C93RI7Z)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
OENOTHERA BIENNIS FLOWERING TOP (UNII: I3Z7321G2F)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76081-010-01300 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/01/2010
Labeler - DUALLIFE CO., LTD. (690403832)
Registrant - DUALLIFE CO., LTD. (690403832)
Establishment
NameAddressID/FEIBusiness Operations
DUALLIFE CO., LTD.690403832manufacture

Revised: 7/2011
Document Id: 18a4c3f0-c2d2-4cae-9389-444ad9c83393
Set id: 80f442ba-e968-4fad-ae41-fa1992008ca4
Version: 3
Effective Time: 20110720
 
DUALLIFE CO., LTD.