Label: ITCH RELIF CVS- diphenhydramine hydrochloride gel

  • 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 4, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                              Purpose
    Diphenhydramine HCI 2%................Topical analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves pain due to: • minor burns • insect bites • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison ivy, poison oak & poison sumac

  • DOSAGE & ADMINISTRATION

    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.

  • WARNINGS

    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 the eyes
    Stop use and ask doctor if • condition gets worse • symptoms last more than 7 days • symptoms clear up and occur again in a few days.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive ingredients:


    Camphor
    Citric Acid
    Diazolidinyl Urea
    Glycerin
    Hydroxypropyl Methylcellulose
    Methylparaben
    Propylene Glycol
    Propylparaben
    SD Alcohol 38-B
    Sodium Citrate
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ITCH RELIF  CVS
    diphenhydramine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-038
    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
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Glycerin (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-038-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/14/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-038) , label(69842-038)
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