Label: ANTI-ITCH- diphenhydramine hci, zinc acetate 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 August 8, 2018

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  • Active ingredients

    Diphenhydramine HCl 2.0%

    Zinc Acetate 0.10%

  • Purpose

    Topical analgesic

    Skin protectant

  • Uses

    Temporarily relieves pain and itching associated with:

    • insect bites
    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • minor skin irritations
    • 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 - Do not use while smoking or near heat or flame ​​​​

  • Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and occur again in a few days
  • WHEN USING

    When using this product

    keep out of eyes, rinse with water to remove
    use only as directed.
    do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F

  • Keep out of reach of children.

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

  • Directions

    • shake well
    • 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
    • to apply to face, spray into palm of hand and gently apply
  • Inactive ingredients

    Alcohol Denat.
    Glycerin
    PVP
    Tromethamine
    Water

  • Questions? 248-449-9300

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    diphenhydramine hci, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-785
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2.0 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-785-0385 g in 1 CAN; Type 0: Not a Combination Product04/07/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/07/2014
    Labeler - Quality Choice (011920774)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(63868-785) , label(63868-785)
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