Label: EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID PHARMACY- diphenhydramine hcl 2% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-7797-4 - 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 January 20, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
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WARNINGS
Warnings
For external use only.
Do not use • on large areas of the body • with any other product containing diphenhydramine, even one taken by mouth
When using this product • avoid contact with the eyes
Stop use and ask doctor if • condition gets worse • symptoms last more than 7 days • symptoms clear up and occur again in a few days. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID PHARMACY
diphenhydramine hcl 2% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-7797 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 Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Glycerin (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Methylparaben (UNII: A2I8C7HI9T) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) ALCOHOL (UNII: 3K9958V90M) Sodium Citrate (UNII: 1Q73Q2JULR) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-7797-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/30/2013 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-7797) , label(11822-7797)