Label: PERSONAL CARE PYRITHIONE ZINC DANDRUFF- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-2216-0 - Packager: Personal Care Products, LLC
- 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 June 29, 2016
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- Official Label (Printer Friendly)
- Drug FactsActive ingredient
- Purpose
- Use
- Warning
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
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Inactive Ingredients
water (aqua), sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, sodium chloride, dimethicone, cetyl alcohol, polyquaternium-10, glycol distearate, disodium EDTA, cocamidopropyl betain, DMDM hydantoin, citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FD and C Blue 1
- Personal Care Dry Scalp Dandruff Shampoo
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INGREDIENTS AND APPEARANCE
PERSONAL CARE PYRITHIONE ZINC DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 4.04 g in 400 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) GLYCOL DISTEARATE (UNII: 13W7MDN21W) EDETATE DISODIUM (UNII: 7FLD91C86K) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DMDM HYDANTOIN (UNII: BYR0546TOW) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-2216-0 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/07/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/07/2011 Labeler - Personal Care Products, LLC (966155082) Registrant - Personal Care Products, LLC (966155082) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co., Ltd 530766098 manufacture(29500-2216)