Label: RITE AID ITCH RELIEF- diphenhydramine hcl 2%, zinc acetate 0.1% spray

  • NDC Code(s): 11822-0647-2, 11822-0647-3
  • 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 July 6, 2022

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  • ACTIVE INGREDIENT

    Diphenhydramine HCl 2%, Zinc Acetate 0.1%

  • PURPOSE


    Topical Analgesic, Skin Protectant

  • INDICATIONS & USAGE

    For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac. Dries the oozing and weeping of poison ivy, oak, and sumac.

  • WARNINGS

    For external use only. Flammable--Keep away from fire or flame. Do not use on chicken pox, on large areas of the body, with any other products containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

  • INACTIVE INGREDIENT

    Alcohol, Glycerin, PVP, Purified Water, Tromethamine.

  • PRINCIPAL DISPLAY PANEL

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    RITE AID ITCH RELIEF 
    diphenhydramine hcl 2%, zinc acetate 0.1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0647
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0647-385 g in 1 CAN; Type 0: Not a Combination Product03/31/2021
    2NDC:11822-0647-259 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2021
    Labeler - Rite Aid (014578892)
    Registrant - Derma Care Research Labs, LLC (116817470)