Label: ALOE VESTA SKIN CONDITIONER- skin conditioner lotion

  • 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 April 14, 2011

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  • Active Ingredient

    Dimethicone 3%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin and lips.
    • Helps treat and prevent diaper rash.
    • Protects minor skin irritation associated with diaper rash and helps seal out wetness.
  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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 consult a Poison Control Center right away.

  • Directions

    For skin protection:
    • Apply as needed.
    For diaper rash:
    • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
    • Apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.
  • Other Information


    Store at 15oC - 30oC (59oF - 86oF).
  • Inactive Ingredients


    Water, Petrolatum, Glycerin, Steareth-2, Cetyl Alcohol, Benzyl Alcohol, Laureth-23, Magnesium Aluminum Silicate, Carbomer, Potassium Sorbate, Sodium Hydroxide, Aloe Barbadensis Leaf Juice.




  • PRINCIPAL DISPLAY PANEL

    Aloe Vesta Skin Conditioner Label

    NDC 43553-3248-4

    ConvaTec

    ALOE VESTATM

    Skin Conditioner 2

    MOISTURIZE

    SKIN PROTECTANT

    Dermatologist Recommended

    Fragrance Free

    Softens

    Moisturizes

    NET WT. 4 fl.oz.(118mL)

    Case Order No. 324804

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA SKIN CONDITIONER 
    skin conditioner lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-3248
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE.03 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LAURETH-23 (UNII: N72LMW566G)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43553-3248-259 mL in 1 BOTTLE
    2NDC:43553-3248-4118 mL in 1 BOTTLE
    3NDC:43553-3248-9236 mL in 1 BOTTLE
    4NDC:43553-3248-13992 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/15/1998
    Labeler - ConvaTec, Inc. (947989757)
    Registrant - ConvaTec, Inc. (947989757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guest Packaging LLC001773076manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Medicia091396697manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ConvaTec, Inc.947989757analysis
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