Label: AFTER BITE OUTDOOR- diphenhydramine hcl gel

  • 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 September 1, 2020

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  • Active Ingredient

    Diphenhydramine HCl 2%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of pain and itching associated with

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • rashes due to poison ivy, poison oak, and poison sumac
  • Warnings

    For external use only

  • Do not use

    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

    Ask a doctor before use

    • on chicken pox
    • on measles
  • When using

    When using this product avoid contact with eyes.

  • Stop use and ask a doctor if

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions

    • do not use more than directed
    • adults and children over 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

    Aloe Vera, Citric Acid, Ethyl Alcohol, Glycerin, Methocel, Methylparaben, Oat Beta Glucan, Propylparaben, Purified Water, Sodium Hydroxide, Tea Tree Oil, Vitamin E

  • Package Labeling

    Box

  • INGREDIENTS AND APPEARANCE
    AFTER BITE OUTDOOR 
    diphenhydramine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-1560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
    OATMEAL (UNII: 8PI54V663Y)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90107-1560-11 in 1 BOX09/01/2020
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:90107-1560-020 g in 1 TUBE; Type 0: Not a Combination Product09/01/2020
    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(90107-1560)
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