Label: DANDRENE- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 72249-100-01 - Packager: DIVINE SKIN LABORATORIES S.A. de C.V.
- 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 November 30, 2020
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- Active ingredient
- Purpose
- Uses
- Warnings
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive ingredients
Water, Sodium Lauryl Sulfoacetate, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Glyceryl Stearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Pomegranage Peel (Punica Granutum) Extract, Rosemary (Rosmarinus Officinalis) Leaf Extract, Shikimic Acid, Tioxolone, Emu Oil, Fragrance, Blue 1
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INGREDIENTS AND APPEARANCE
DANDRENE
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72249-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 20 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) TROLAMINE (UNII: 9O3K93S3TK) GLYCOLIC ACID (UNII: 0WT12SX38S) COCO MONOETHANOLAMIDE (UNII: C80684146D) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SODIUM CITRATE (UNII: 1Q73Q2JULR) HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L) LUPINUS ALBUS SEED (UNII: 24GB753W3B) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POMEGRANATE FRUIT RIND (UNII: RS999V57DU) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) SHIKIMIC ACID (UNII: 29MS2WI2NU) TIOXOLONE (UNII: S0FAJ1R9CD) EMU OIL (UNII: 344821WD61) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72249-100-01 1 in 1 BOX 10/01/2018 1 205 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/01/2018 Labeler - DIVINE SKIN LABORATORIES S.A. de C.V. (812464196) Establishment Name Address ID/FEI Business Operations A.I.G. Technologies, Inc. 086365223 manufacture(72249-100) , label(72249-100) , pack(72249-100)