Label: PERT PLUS 2 IN 1 ANTI-DANDRUFF- pyrithione zinc shampoo, suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 41595-8001-1, 41595-8001-2 - Packager: Idelle Labs, 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 August 23, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients: Water, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Sodium Chloride, Glycol Distearate, Dimethicone, Fragrance, Polyquaternium 10, Guar Hydroxypropyltrimonium Chloride, Cocamide MEA, Cetyl Alcohol, PEG-7M, Trimethylolpropane tricaprylate/tricaprate, Hydrogenated Polydecene, Sodium Benzoate, Citric Acid, Sodium Citrate, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 10.
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INGREDIENTS AND APPEARANCE
PERT PLUS 2 IN 1 ANTI-DANDRUFF
pyrithione zinc shampoo, suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41595-8001 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) AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) GLYCOL DISTEARATE (UNII: 13W7MDN21W) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL) TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41595-8001-1 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2018 2 NDC:41595-8001-2 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/10/2018 Labeler - Idelle Labs, Ltd (128822926)