Label: ANTI-ITCH- diphenhydramine hcl gel

  • Category: HUMAN OTC DRUG LABEL

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 18, 2013

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  • Active ingredients (in each gram)

    Diphenhydramine HCl 2%

  • Purposes

    Topical analgesic

    Skin protectant

  • Uses

    • temporarily relieves itching and pain associated with insect bites, minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
    • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
  • Warnings

    For external use only

    Do not use

    • on chicken pox or measles
    • with any other product containing diphenhydramine, even one taken by mouth
    • on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • 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

    • adults and children 12 years of age and over:  apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:  ask a doctor
    • do not use more often than directed
  • Other information

    • store at 15°-25°C (59°-77°F)
  • Inactive ingredients

    camphor, citric acid, ethanol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • Package label

    Anti-Itch Gelimage of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    diphenhydramine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-076-01113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/18/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
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