Label: CLEAN APPLE- pyrithione zinc shampoo
- NDC Code(s): 72288-012-15, 72288-012-39
- Packager: Amazon.Com Services 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 September 11, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
-
Inactive ingredients
water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5
- SPL UNCLASSIFIED SECTION
- principal display panel
- principal display panel
- principal display panel
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INGREDIENTS AND APPEARANCE
CLEAN APPLE
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-012 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 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) GLYCOL DISTEARATE (UNII: 13W7MDN21W) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC CARBONATE (UNII: EQR32Y7H0M) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM BENZOATE (UNII: OJ245FE5EU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-012-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2018 2 NDC:72288-012-39 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/01/2018 Labeler - Amazon.Com Services LLC (128990418) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72288-012) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72288-012)
