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DAMOAE THERAPY

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 3g in 300g
Labeler: DUALLIFE CO., LTD.
NDC Code: 76081-010

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

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.

DAMOAE THERAPY 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76081-010
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE) PYRITHIONE ZINC3 g  in 300 g
Inactive Ingredients
Ingredient NameStrength
biotin 
NIACINAMIDE 
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 
Packaging
#Item CodePackage Description
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/FEIOperations
DUALLIFE CO., LTD.690403832manufacture

Revised: 07/2011
 
DUALLIFE CO., LTD.

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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