You are here: Home > Over-the-counter (OTC) Drugs > A > Aloe Vesta Protective Barrier (Convatec, Inc.)

Name:Aloe Vesta Protective Barrier
Manufacturer:Convatec, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALOE VESTA PROTECTIVE BARRIER  - petrolatum spray 
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 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


ALOE VESTA PROTECTIVE BARRIER 
petrolatum spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43553-4134
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 360 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
HEXAMETHYLDISILOXANE  
MINERAL OIL  
ALOE VERA LEAF  
Product Characteristics
Color white (Off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43553-4134-1 60 g in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/13/2005

Labeler - ConvaTec, Inc. (947989757)
Registrant - ConvaTec, Inc. (947989757)
Establishment
Name Address ID/FEI Operations
Aurena 355607748 manufacture
Establishment
Name Address ID/FEI Operations
ConvaTec, Inc. 947989757 analysis

Revised: 04/2011 ConvaTec, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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