Label: DAMOAE THERAPY- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 76081-010-01 - Packager: DUALLIFE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated July 20, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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
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WARNINGS
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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAMOAE THERAPY
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76081-010 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE - UNII:6GK82EC25D) PYRITHIONE ZINC 3 g in 300 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76081-010-01 300 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 08/01/2010 Labeler - DUALLIFE CO., LTD. (690403832) Registrant - DUALLIFE CO., LTD. (690403832) Establishment Name Address ID/FEI Business Operations DUALLIFE CO., LTD. 690403832 manufacture