Label: ALOE VESTA DAILY MOISTURIZER 59 ML- dimethicone 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 August 6, 2016

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  • Drug Facts

  • INDICATIONS & USAGE

    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

    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

    Keep out of reach of children. If swallowed, get medical help or consult a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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.

  • Active ingredient

    Dimethicone 3%

  • Purpose

    Skin Protectant

  • INACTIVE INGREDIENT

    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.

  • STORAGE AND HANDLING

    Store at 15°C to 30°C (59°F - 86°F )

  • SPL UNCLASSIFIED SECTION

    • Skin Protectant
    • CHG Compatible
    • Dermatologist Recommended
    • Fragrance & Dye Free
    • Clear In Use
    • For All Ages

    with 3 percent Dimethicone and a Natural Botanical


    Manufactured for:
    ConvaTec
    ConvaTec Inc.
    Greensboro, NC 27409
    1-800-422-8811
    www.convatec.com

    Made in USA

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA DAILY MOISTURIZER 59 ML 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11099-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.77 g  in 59 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 HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11099-0001-259 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/09/2016
    Labeler - Guest Packaging LLC. (001773076)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guest Packaging LLC.001773076manufacture(11099-0001)
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