Label: ROYAL DANDRUFF DRY SCALP CARE- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-300-01 - Packager: Filo America
- Category: HUMAN OTC DRUG LABEL
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 September 17, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROYAL DANDRUFF DRY SCALP CARE
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cocamidopropyl betaine (UNII: 5OCF3O11KX) glycol stearate (UNII: 0324G66D0E) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) ammonium chloride (UNII: 01Q9PC255D) methylchloroisothiazolinone (UNII: DEL7T5QRPN) methylisothiazolinone (UNII: 229D0E1QFA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-300-01 350 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/17/2013 Labeler - Filo America (943873703) Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265) Establishment Name Address ID/FEI Business Operations NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265 manufacture(50438-300)