ITCH RELIEF CREAM (HYDROCORTISONE CREAM) CREAM [CINTAS]

ITCH RELIEF CREAM (HYDROCORTISONE CREAM) CREAM [CINTAS]
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NDC 42961-370-09
Set ID 65817c17-5ecb-4f2f-b588-4354329c1942
Category HUMAN OTC DRUG LABEL
Packager Cintas Corporation
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: HYDROCORTISONE 1%Cream.

  • PURPOSE

    Itch Relief Cream

  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzoic Acid, Chlorphenesin, Citric Acid, Glycerin,Glycerol Monostearate, Methyl Paraben, Mineral Oil,Petrolatum, Phenoxyethanol,Polysorbate 80,Purified Water, Titanium Dioxide,Trisodium Citrate

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    USES: For the temporary relief of itching associated with minor, skin irritations and rashes due to eczema, insect bites, poison ivy/oak/sumac, soaps, detergents,cosmetics and jewelry

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children 2years of age and older: apply to affected area and not more than 3 to4 times daity. Children under 2: do not use, consult a doctor.

  • WARNINGS

    WARNINGS: For external use only. Avoid contact with eyes. Discontinue use If conditions persist more than 7 days and consult a physician. Do not use on children under 2 years except under the advice and supervision of a physician. Do not use with any other hydrocortisone product unless you have consulted a doctor. Other uses or this product should be only under the advise or supervision of a doctor.

  • OTHER SAFETY INFORMATION

    Store at room temperature (do not freeze).

    PACKET NOT FOR INDIVIDUAL SALE

    Tamper evident: Do not use if package is torn or cut.

  • PRINCIPAL DISPLAY PANEL

    Cintas HC cream 2016

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF CREAM 
    hydrocortisone cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-370-090.9 g in 1 PACKET; Type 0: Not a Combination Product11/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/29/2016
    Labeler - Cintas Corporation (056481716)
    Registrant - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc. 151051757manufacture(42961-370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation 085752004pack(42961-370)

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