Label: THE ITCH ERASER- diphenhydramine hydrochloride spray

  • NDC Code(s): 90107-2410-1
  • Packager: Adventure Ready Brands
  • 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 19, 2023

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

  • ​Drug Facts

  • ​Active ingredients:

    Diphenhydramine HCl 2%

  • ​Purpose:

    Topical analgesic

  • ​Uses

    ​For temporary relief of pain and itching associated with:

    • minor burns

    • sunburn

    • minor cuts

    • insect bites

    • minor skin irritations

    • rashes due to poison ivy, poison oak, and poison sumac

  • ​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

  • Ask a doctor before use

    • on chicken pox • on measles

  • When using this product

    avoid contact with the eyes.

  • Stop use and ask a doctor if

    • condition worsens • 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 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.
  • ​Inactive Ingredients

    Glycerin, Oat Beta Glucan, Povidone, Purified Water, SD Alcohol 40-2, Sodium Bicarbonate (Baking Soda), Tea Tree Oil, Vitamin E Acetate, Zinc Acetate

  • Package Labeling

    Box

  • INGREDIENTS AND APPEARANCE
    THE ITCH ERASER 
    diphenhydramine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-2410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OAT (UNII: Z6J799EAJK)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC ACETATE (UNII: FM5526K07A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90107-2410-11 in 1 BOX09/01/2020
    128 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2020
    Labeler - Adventure Ready Brands (064437304)
    Registrant - Adventure Ready Brands (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adventure Ready Brands064437304manufacture(90107-2410)