ITCH STOPPING (DIPHENHYDRAMINE HCL) GEL [CHAIN DRUG MARKETING ASSOCIATION]

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ITCH STOPPING (DIPHENHYDRAMINE HCL) GEL [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-260-04
Set ID 884c9b47-d511-1d17-e053-2995a90a42eb
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Diphenhydramine hydrochloride 2%............................................................................................... Topical analgesic

  • Uses

    temporary relieves pain and itching due to:

    insect bites

    minor burns

    sunburn

    minor skin irritations

    minor cuts

    scrapes

    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 Doctor Before Use

    On chiken Pox

    On Measles

    When Using This Product

    do not get into eyes

    Stop Use and ask 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.

  • Purpose

    Anti itch

  • Directions

    do not use more often than directed

    adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

  • Other

    store at 20 °C to 25 °C (68 °F to 77 °F)

  • Inactive Ingredients

    camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water,
    SD alcohol 40-B, sodium citrate

  • dosage and administration

    adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

  • Principal Dipslay label

    Quality Choice QC

    Compare to the active ingredient in Benadryl Gel

    Extra strength Itch Relief Gel

    Topical Analgesic

    Diphenhydramine HCL 2%

    For skin use only

    QC choice Gel .jpg

  • INGREDIENTS AND APPEARANCE
    ITCH STOPPING 
    diphenhydramine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-260
    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
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-260-04113 g in 1 BOTTLE; Type 0: Not a Combination Product05/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/14/2014
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Weeks & Leo (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    weeks and Leo005290028manufacture(63868-260)
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