ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES, LLC.]

  • Home
  • ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES, LLC.]

ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES, LLC.]
PDF | XML
NDC 59898-810-10
Set ID 98b35828-912c-4d08-b5b2-4829aee85742
Category HUMAN OTC DRUG LABEL
Packager Water-Jel Technologies, LLC.
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs