Label: ALOE VESTA- dimethicone lotion

  • NDC Code(s): 53329-775-04, 53329-775-08, 53329-775-13
  • Packager: Medline Industries, LP
  • 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 17, 2023

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  • Active ingredient

    Dimethicone 3% w/v

  • 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 protections:
    • 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 15°C-30°C (59°F-86°F)
  • Inactive ingredients

    aloe barbadensis leaf juice, benzyl alcohol, carbomer, cetyl alcohol, glycerin, steareth-2, laureth-23, magnesium aluminum silicate, water, white petrolatum

  • Manufacturing Information

    Manufactured by: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL60093 USA

    Made in USA of foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: 324804

    V1RE21GSG

  • Package Label

    Aloe Vesta Daily Moisturizer

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-775
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LAURETH-23 (UNII: N72LMW566G)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    STEARETH-2 (UNII: V56DFE46J5)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-775-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/202105/31/2025
    2NDC:53329-775-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/202105/31/2025
    3NDC:53329-775-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/202103/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01607/01/202105/31/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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