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ALOE VESTA PROTECTIVE

Dosage form: ointment
Ingredients: PETROLATUM 430mg in 1g
Labeler: ConvaTec, Inc.
NDC Code: 43553-3249

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 43%

Purpose

Skin Protectant

Uses
  • Temporarily protects minor
  • cuts
  • scrapes
  • burns.
  • 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 see a doctor ifcondition lasts more than 7 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 IngredientsWater, Mineral Oil, Hydroxylated Lanolin, Sorbitan Sesquioleate, Ozokerite, PEG-30 Dipolyhydroxystearate, Glycerin, Steareth-20, Magnesium Sulfate, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Aloe Barbedensis Leaf Juice.

PRINCIPAL DISPLAY PANEL



NDC 43553-3249-3

ConvaTec

ALOE VESTATM

Protective Ointment 3

PROTECT

SKIN PROTECTANT

Hypoallergenic

Fragrance Free

NET WT. 2oz.(56g)
ALOE VESTA PROTECTIVE 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-3249
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM430 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
SORBITAN SESQUIOLEATE 
LANOLIN 
PEG-30 DIPOLYHYDROXYSTEARATE 
GLYCERIN 
STEARETH-20 
MAGNESIUM SULFATE, UNSPECIFIED 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
ALOE VERA LEAF 
Product Characteristics
Colorwhite (Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43553-3249-356 g in 1 TUBE
2NDC:43553-3249-8226 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/23/2001
Labeler - ConvaTec, Inc. (947989757)
Registrant - ConvaTec, Inc. (947989757)
Establishment
NameAddressID/FEIOperations
Accupac Inc.071609663manufacture
Establishment
NameAddressID/FEIOperations
Medicia091396697manufacture
Establishment
NameAddressID/FEIOperations
ConvaTec, Inc.947989757analysis
Establishment
NameAddressID/FEIOperations
Apex International015226132manufacture

Revised: 07/2011
Document Id: 2e339255-3a02-483b-8b94-21398fbc9f7a
Set id: e20c23ee-8288-4c36-b15b-a04df2d7c7d9
Version: 4
Effective Time: 20110707
 
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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