CVS MAXIMUM STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [CVS PHARMACY]

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CVS MAXIMUM STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [CVS PHARMACY]
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NDC 59779-048-69
Set ID baa7ae0b-dfce-4f56-a26b-5bfe31099b66
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART336
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  • ACTIVE INGREDIENT

    Active ingredient                                                               Purpose

    Diphenhydramine HCL 2% ...................................................................Topical analgesic

  • PURPOSE



    Uses

    Temporarily relieves pain and itching associated with
    - minor burns - insect bites - sunburn - minor skin irritations
    - minor cuts - scrapes - rashes due to poison ivy, poison oak and poison sumac

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact a
    Poison Control Center right away.

  • INDICATIONS & USAGE


    Uses

    Temporarily relieves pain and itching associated with
    - minor burns - insect bites - sunburn - minor skin irritations
    - minor cuts - scrapes - rashes due to poison ivy, poison oak and poison sumac
  • 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 a doctor if condition worsens,
    or if the symptoms persist for more than 7 days
    or clear up and occur again within a few days.

    Keep out of reach of children.     If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION


    Directions

    - do not use more than directed

    - Adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

    - Children under 2 years of age:     ask a doctor

    Other information

    Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    purified water, SD alcohol 40-B, propylene glycol, diazolidinyl urea, hydroxypropyl methylcellolose, camphor, methylparaben, citric acid, sodium citrate, propylparaben
  • PRINCIPAL DISPLAY PANEL

    label



  • INGREDIENTS AND APPEARANCE
    CVS  MAXIMUM STRENGTH ITCH RELIEF
    diphenhydramine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-048-69118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/10/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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