Label: DIPHENHYDRAMINE HCI AND ZINC ACETATE- itch relief continuous spray aerosol, spray

  • 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 30, 2019

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  • Active Ingredients

    Diphenhydramine HCI 2.0%

    Zinc Acetate 0.1%

  • Purpose

    External Analgesic

    Skin Protectant

  • Uses

    for the temporary relief of pain and itching associated with:

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
    • rashes due to poison ivy, poison oak and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac
  • Warnings

    For external use only.

    Flammable:

    Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    Do not use

    • on lare areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • avoid contact with eyes

    Stop use and ask doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of the reach of children.

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

  • Directions

    • do not use more often than directed
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other Information

    store between 20º to 25ºC (68º to 77ºF)

  • Inactive Ingredients

    aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    CAREONE

    Extra Strength Itch Relief Continuous Spray

    Diphenhydramine Hydrochloride/

    External Analgesic

    Zinc Acetate / Skin Protectant

    RELIEFS ITCHING FROM

    INSECT BITES AND POISON

    IVY, OAK & SUMAC

    SOOTHES SUNBURN

    AND MINOR BURNS & CUTS

    NET WT 2.7 OZ (76g)

    Careone Itch Relief Continuous Spray

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCI AND ZINC ACETATE 
    itch relief continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMODIPHENHYDRAMINE HYDROCHLORIDE (UNII: 202J683U97) (BROMODIPHENHYDRAMINE - UNII:T032BI7727) BROMODIPHENHYDRAMINE HYDROCHLORIDE1.52 g  in 76 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.076 g  in 76 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-090-7676 g in 1 CANISTER; Type 0: Not a Combination Product03/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/04/2019
    Labeler - Foodhold USA (809183973)
    Registrant - Premier Brands of America Inc. (063849780)
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