Label: TINY TILLIA- 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 26, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient
    Zinc Oxide 10%...........................

                                  Purpose

    .......................skin protectant

  • INDICATIONS & USAGE

    Uses

    • Helps treat and prevent diaper rash.
    • Protects from minor skin irritations due to diaper rash and helps seal out wetness.
  • DOSAGE & ADMINISTRATION

    Directions

    • Change wet and soiled diapers promptly.
    • Cleanse the diaper area and allow to dry.
    • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • INACTIVE INGREDIENT

     Inactive ingredients

    WATER/EAU
         PETROLATUM
         MINERAL OIL/HUILE MINERALE
         BUTYLENE GLYCOL
         GLYCERIN
         BEESWAX/CIRE D'ABEILLE
         CETYL PEG/PPG-10/1 DIMETHICONE
         MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
         POLYGLYCERYL-4 ISOSTEARATE
         ISOSTEARIC ACID
         SODIUM CHLORIDE
         ALOE BARBADENSIS LEAF JUICE
         TOCOPHERYL ACETATE
         CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT
         DIMETHICONE
         PHENOXYETHANOL
         CAPRYLYL GLYCOL
         XANTHAN GUM
         

  • QUESTIONS

    QUESTIONS? Call 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFB

  • WARNINGS

    Warnings
    FOR EXTERNAL USE ONLY.

    When using this product
    • Do not get into eyes.

    Stop use and ask a doctor if
    • condition worsens
    • symptoms last 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.

  • GENERAL PRECAUTIONS

    Other information
    DO NOT USE IF SEAL IS
    BROKEN.
    • Store at room temperature.

  • INGREDIENTS AND APPEARANCE
    TINY TILLIA 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0242-1100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/26/2011
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture
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