Label: ITCH RELIEF GEL- diphenhydramine hcl gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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  • Active ingredient

    Diphenhydramine HCL 2%

  • Purpose

    Topical Analgesic

  • Use

    Temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor cuts, scrapes, 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 eyes

  • Stop use and ask a doctor if

    condition worsens, symptoms persist for 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.

  • Other information

    Store at room temperature

  • Inactive ingredients

    camphor, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

  • Questions?

    1-800-925-4733

  • Directions

    Apply to affected area not more thatn 3 to 4 times daily

  • Tube label

    Tube label

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF GEL 
    diphenhydramine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0353
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0353-04103.5 mL in 1 TUBE; Type 0: Not a Combination Product05/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/30/2018
    Labeler - Walgreens (008965063)
    Registrant - Unipack LLC (116015769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(0363-0353)
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