Label: HAPPY CAPPY- pyrithione zinc shampoo
- NDC Code(s): 71566-100-08, 71566-100-11
- Packager: Pediatric Solutions, LLC
- 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 October 4, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions •
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Inactive ingredients
Water (Aqua), Glycerin, Sodium Lauroyl Methyl Isethionate, Sodium Laurylglucosides Hydroxypropylsulfonate, Cocamidopropyl Hydroxysultaine, Acrylates Copolymer, Pyrus Malus (Apple) Fruit Extract, Phenoxyethanol, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Dipotassium Glycyrrhizate, Panthenol, Ethylhexylglycerin, Citric Acid.
- Principal Display Panel - 237 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HAPPY CAPPY
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71566-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pyrithione zinc (UNII: R953O2RHZ5) (pyrithione zinc - UNII:R953O2RHZ5) pyrithione zinc 0.0095 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Sodium Lauroyl Methyl Isethionate (UNII: II6VCD3S6R) Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W) Acrylic Acid/Isophorone Diisocyanate/PEG-27 Copolymer (UNII: R0R8I3X29J) Apple (UNII: B423VGH5S9) Phenoxyethanol (UNII: HIE492ZZ3T) Sodium Chloride (UNII: 451W47IQ8X) Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) (UNII: B16G315W7A) Sodium Hydroxide (UNII: 55X04QC32I) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Panthenol (UNII: WV9CM0O67Z) Ethylhexylglycerin (UNII: 147D247K3P) Citric Acid Monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71566-100-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/07/2017 2 NDC:71566-100-11 15 mL in 1 PACKET; Type 0: Not a Combination Product 09/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/07/2017 Labeler - Pediatric Solutions, LLC (080736513) Establishment Name Address ID/FEI Business Operations Minimus Products LLC 022997834 PACK(71566-100) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 MANUFACTURE(71566-100)