Label: DERMAHARMONY ZINC THERAPY- pyrithione zinc liquid
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NDC Code(s):
71819-016-04,
71819-016-10,
71819-016-12,
71819-016-64, view more71819-016-99
- Packager: D3 Development, Inc.
- 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 September 5, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMAHARMONY ZINC THERAPY
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71819-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 2 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18) DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI) TEA TREE OIL (UNII: VIF565UC2G) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71819-016-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/05/2021 2 NDC:71819-016-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/05/2021 3 NDC:71819-016-64 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/05/2021 4 NDC:71819-016-99 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/05/2021 5 NDC:71819-016-10 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/05/2021 Labeler - D3 Development, Inc. (043195877)