Label: ITCH RELIEF - diphenhydramine hydrochloride spray 

  • Label RSS
  • NDC Code(s): 59898-810-10
  • Packager: Water-Jel Technologies
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/10

If you are a consumer or patient please visit this version.

  • Active ingredient

    Diphenhydramine hydrochloride 2%

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  • Purpose

    External analgesic

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  • Uses

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

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  • Warnings

    For external use only

    Do not use

    • on poison ivy or sunburn
    • on broken, blistered or oozing skin
    • 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 or measles

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control  Center right away

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  • Directions

    • do not use more often than directed
    • adults and children 2 years of age and older: apply to the affected area not more than 3 - 4 times daily
    • children under 2 years: consult a doctor
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  • Other information

    • store at room temperature
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  • Inactive ingredients

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

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  • Questions or comments?

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

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59898-810
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine Hydrochloride (Diphenhydramine ) Diphenhydramine Hydrochloride 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    DIAZOLIDINYL UREA  
    EDETATE DISODIUM  
    HYPROMELLOSE  
    METHYLPARABEN  
    OCTOXYNOL 9  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59898-810-10 59 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/25/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture
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