Label: PREMIER VALUE ALLERGY- diphenhydramine hydrochloride cream

  • 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 September 17, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredients                                                                            Purpose

    Diphenhydramine Hydrochloride USP, 2% .........................................Topical analgesic

    Zinc acetate, 0.1% .........................................................................Skin Protectant

  • PURPOSE

    Uses

    Temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak, and poison sumac. Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use on large area of the body or with any other product containing diphenhydramine, even one taken by mouth.

  • ASK DOCTOR

    Ask a doctor before use

    on chicken pox or on measles.

  • WHEN USING

    When using this product

    avoid contact with the eyes.

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve within 7 days, or symptoms persist for more than 7 days, or clear up and occur again within a few days.

  • 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

    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, or as directed by a doctor
    • children under 2 years of age: consult a doctor
    • discontinue use and consult a physician if rash or irritation develops
  • STORAGE AND HANDLING

    Other information

    • store at 20o to 25oC (68o to 77oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • DOSAGE & ADMINISTRATION

    Distributed By:

    Chain Drug Consortium, LLC.

    3301 N.W. Boca Raton Blvd., Suite 101

    Boca Raton, FL 33431

  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, sodium chloride, petrolatum, cetyl alcoho, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water, hydroxyethyl cellulose

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE ALLERGY  
    diphenhydramine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-0127-61 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/17/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture