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ALOE VESTA PROTECTIVE BARRIER

Dosage form: spray
Ingredients: PETROLATUM 360mg in 1g
Labeler: ConvaTec, Inc.
NDC Code: 43553-4134

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 Facts

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

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

ALOE VESTA PROTECTIVE BARRIER 
petrolatum spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-4134
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM360 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXAMETHYLDISILOXANE 
MINERAL OIL 
ALOE VERA LEAF 
Product Characteristics
Colorwhite (Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Aurena355607748manufacture
Establishment
NameAddressID/FEIOperations
ConvaTec, Inc.947989757analysis

Revised: 04/2011
Document Id: c83c8a0d-a979-4024-9f02-01392449ecbc
Set id: 10341c96-b4ba-4892-ab68-2ac66f29da96
Version: 3
Effective Time: 20110408
 
ConvaTec, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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