Label: DENINO DIAPER RASH- rash prevention cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 26, 2010

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  • Drug Facts

    Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.

  • Directions for use

    Directions for use: Apply a thick layer to the affected area on each diaper change, after cleansing and drying skin completely.

  • WARNINGS

    Warnings: Do not apply to an open wound. Stop use and ask doctor if irritation or rash persists.

  • ACTIVE INGREDIENT

    Zinc oxide, Avena Sativa Flowering Top, Medium-Chain Triglycerides, Lanolin, Matricaria Recutita, Allantoin, Calendula Officinalis Flower.

  • INACTIVE INGREDIENT

    Other Ingredients: Petrolatum, Yellow Wax, Sorbitan Monostereate, Glycerlyl Monostearate, Stearyl Alcohol, Butylated Hydroxytoluene.

  • REFERENCES

    Made in Mexico by Corpsain SA de CV.

    www.corpsain.com   sales@corpsain.com

    Phone +(52) 81 83 46 5800

    Imported and Distributed by Montdani International LCC. info@Montdani.com

    Phone (830) 626 0468

  • PRINCIPAL DISPLAY PANEL

    diaperrash2oz.jpg

  • INGREDIENTS AND APPEARANCE
    DENINO DIAPER RASH 
    rash prevention cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50760-8051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.8 mL  in 60 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP.6 mL  in 60 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES18.21 mL  in 60 mL
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN2.4 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    WAX, YELLOW (UNII: 2ZA36H0S2V)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50760-8051-660 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2010
    Labeler - Corpsain SA de CV (814593448)
    Establishment
    NameAddressID/FEIBusiness Operations
    Corpsain SA de CV814593448manufacture, label
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