Label: ITCH RELIEF- diphenhydramine hydrochloride spray

  • NDC Code(s): 59898-810-10
  • Packager: Water-Jel Technologies, LLC.
  • 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 December 22, 2020

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  • Active ingredient

    Diphenhydramine hydrochloride 2%

  • Purpose

    External analgesic

  • Uses

    for temporary relief of pain and itching associated with minor bums, minor cuts, scrapes, insect bites or minor skin irritations

  • WARNINGS

    For external use only

    Do not use

    • on large areas of the body

    • on broken, blistered or oozing skin • on poison ivy or sunburn
    • more often than directed
    • wtth any other product containing diphenhydramlne, even one taken by mouth
    • on chicken pox or measles

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens • symptoms persist for more than 7 days • condition clears up and occurs again within 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 2 years of age and older:

    apply to affected area not more than 3-4 times daily

    • children under 2 years: consult a doctor

  • Other Information

    • store at room temperature
    • you may report a serious adverse reaction to this product to 1-800-275-3433

  • Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

  • Questions or comments?

    1-800-275-3433 info@waterjel.com www.waterjel.com

    Manufactured by Water-Jel Technologies Inc.

    50 Broad Street, Carlstadt, NJ 07072

  • Principal Display Panel

    AI2

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-810-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/25/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/25/2010
    Labeler - Water-Jel Technologies, LLC. (155522589)
    Registrant - Water-Jel Technologies, LLC. (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies, LLC.155522589manufacture(59898-810)
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