Label: BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride gel

  • NDC Code(s): 69968-0242-3
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 June 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • children under 2 years of age: ask a doctor
  • Other information

    Store at Room Temperature

  • Inactive ingredients

    SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • Questions or comments?

    call 1-877-717-2824 (toll free) or 215-273-8755 (collect) www.benadryl.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 103 mL Tube Label

    Benadryl®

    ®

    Cooling relief for

    most outdoor itches

    EXTRA STRENGTH

    For Skin Use Only

    ITCH STOPPING

    GEL

    Diphenhydramine HCl 2% /

    Topical Analgesic

    Insect

    Bites     		Poison Ivy,

    Oak, Sumac     		Mosquito

    Bites     		SunburnMinor Cuts

    & Scrapes

    3.5 FL OZ (103 mL)

    Benadryl_01

  • INGREDIENTS AND APPEARANCE
    BENADRYL EXTRA STRENGTH ITCH STOPPING 
    diphenhydramine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0242
    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
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0242-3103 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2013
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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