Label: ANTI-ITCH- diphenhydramine hci, zinc acetate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-785-03 - Packager: Quality Choice
- 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 August 8, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor if
- WHEN USING
- Keep out of reach of children.
- Directions
- Inactive ingredients
- Questions? 248-449-9300
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-ITCH
diphenhydramine hci, zinc acetate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-785 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2.0 g in 100 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION .10 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) TROMETHAMINE (UNII: 023C2WHX2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-785-03 85 g in 1 CAN; Type 0: Not a Combination Product 04/07/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/07/2014 Labeler - Quality Choice (011920774) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(63868-785) , label(63868-785)