Label: ALOE VESTA PROTECTIVE BARRIER- petrolatum spray

  • 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 8, 2011

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  • Active Ingredient

    Petrolatum 36%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor
    • cuts
    • scrapes
    • burns.

    • Temporarily protects and helps relieve chapped or cracked skin.
    • 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

    • avoid spraying in eyes
    • do not intentionally inhale.

    Stop use and see a doctor if

    condition lasts more than 7 days.

    Keep out of reach of children.

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

    Flammable

    Contents under pressure

    • Keep away from heat, sparks, and open flame.
    • Do not puncture or incinerate container.
    • Exposure to temperatures above 120oF may cause bursting.
  • Directions

    Do not overspray.  Shake before use.  Hold can 4-6 inches from skin and spray.

    For skin protection

    • Apply a thin continuous coating as needed.
    For diaper rash

    • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.  Apply as needed, 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

    Hexamethyldisiloxane, Softisan 649, Mineral Oil, Aloe Extract.

  • PRINCIPAL DISPLAY PANEL


    Aloe Vesta Protective Barrier Spray Label

    NDC 43553-4134-1

    ConvaTec

    ALOE VESTATM

    Protective Barrier Spray 3

    PROTECT

    SKIN PROTECTANT

    Shake before use

    Soothes irritated skin

    For weepy, denuded skin

    Apply from any angle

    Easy to remove

    NET WT. 2.1 oz.(60g)

    CSX1876A  Case Order No. 413401

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA PROTECTIVE BARRIER 
    petrolatum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-4134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM360 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Colorwhite (Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43553-4134-160 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/13/2005
    Labeler - ConvaTec, Inc. (947989757)
    Registrant - ConvaTec, Inc. (947989757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurena355607748manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ConvaTec, Inc.947989757analysis
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