Label: FORMULA 21 DIAPER RASH- zinc oxide 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 January 24, 2012

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  • Active Ingredient

    Zinc Oxide 25%

    Purpose

    Skin Protectant

  • Uses

    Helps treat and prevent diaper rash. Protects minor skin irritation due to diaper rash and helps protect from wetness.

  • Warnings

    For external use only.

    When using this product

    Do not get in eyes.

    Stop use and as doctor if

    • conditions worsen
    • symptoms last more than 7 days or clear up and return again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply product liberally as often as necessary, with each diaper change especially at bedtime or any time when exposure to wet diapers may be prolonged.

  • Inactive Ingredients

    Glycerin, Purified Water, Talc

  • Product Label

    Formula 21
    Zinc Oxide 25%

    Skin Protectant

    Not Greasy!

    Protector

    Diaper Rash - Rapid Relief- Shake before use - Cream

    1 fl. oz. (30ml)

    Distributed by DRA Bello Products, Inc.
    1627 Gessner Dr. Suite 3
    Houston TX 77080

    www.drabello.tv

    713-932-9100


    Diaper Rash Cream



    Diaper Rash Cream




  • INGREDIENTS AND APPEARANCE
    FORMULA 21 DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42416-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE25 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42416-0021-130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/26/2012
    Labeler - DRA Bello Products, Inc. (078272165)
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