ITCH RELIF CVS (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [CVS]

ITCH RELIF CVS (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [CVS]
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NDC 69842-038-04
Set ID 8ead8d43-2757-4937-b21d-94395990c371
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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