Label: EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID- diphenhydramine hcl 2% zinc acetate 0.1% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-7796-2 - Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 18, 2018
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- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- Uses
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WarningsFor external use only.Flammable. Keep away from fire or flame.
Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body
Stop use and ask a doctor if
• condition worsens or does not improve within 7 days
• symptoms persist more than 7 days or clear up and occur again within a few days - Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID
diphenhydramine hcl 2% zinc acetate 0.1% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-7796 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 mL ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.1 g in 100 mL 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:11822-7796-2 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/10/2013 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-7796) , label(11822-7796)