Label: ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

  • NDC Code(s): 70000-0023-1
  • Packager: Cardinal Health, 110 dba Leader
  • 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 November 10, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Diphenhydramine HCl 2%
    Zinc Acetate 0.1%

    Purpose

    External analgesic
    Skin protectant

  • Uses

    • for the temporary relief of pain and itching associated with minor skin irritations
    • dries the oozing and weeping of poison: ivy, oak, sumac
  • Warnings

    For external use only

    Flammable

    Keep away from fire of flame.

    Do not use

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

    Ask a doctor before use

    on chicken pox or measles

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    condition worsens or symptoms last 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.

  • Directions

    • do not use more 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 at 20⁰ - 25⁰C (68⁰ - 77⁰F)

  • Inactive ingredients

    alcohol, glycerin, povidone, purified water, tris (hydroxymethyl)aminomethane

  • Questions & comments?

    1-800-593-0593

  • Adverse reactions

    Dist. by CAH, Dublin, OH 43017

    2019 Cardinal Health

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company of the registered trademark Benadryl Extra Strength Spray.

  • principal display panel

    TEAR HERE

    LEADER

    NDC 70000-0023-1

    Extra Strength

    Itch Relief Spray

    Diphenhydramine HCI, 2% Zinck Acetate, 0.1%

    External Analgesic

    Skin Protectant

    COMPARE TO BENADRYL EXTRA STRENGTH SPRAY

    active ingredients

    100% Money Back Guarantee

    Relieves Itching

    Due to Insect Bits,

    Poison Oak or Ivy, or Other Minor Skin Irritations

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hcl, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
    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:70000-0023-159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/02/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/02/2011
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(70000-0023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(70000-0023)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!