ALOE VESTA PROTECTIVE - petrolatum ointment 
ConvaTec, Inc.

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.

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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 if

condition 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 Ingredients

Water, 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


Aloe Vesta Protective Ointment Label



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 DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Accupac Inc.071609663manufacture
Establishment
NameAddressID/FEIBusiness Operations
Medicia091396697manufacture
Establishment
NameAddressID/FEIBusiness Operations
ConvaTec, Inc.947989757analysis
Establishment
NameAddressID/FEIBusiness Operations
Apex International015226132manufacture

Revised: 7/2011
 
ConvaTec, Inc.