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ALOE VESTA SKIN CONDITIONER

Dosage form: lotion
Ingredients: DIMETHICONE .03mg in 1mL
Labeler: ConvaTec, Inc.
NDC Code: 43553-3248

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

Dimethicone 3%

Purpose

Skin Protectant

Uses
  • 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 ask a doctor if
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few 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, Petrolatum, Glycerin, Steareth-2, Cetyl Alcohol, Benzyl Alcohol, Laureth-23, Magnesium Aluminum Silicate, Carbomer, Potassium Sorbate, Sodium Hydroxide, Aloe Barbadensis Leaf Juice.




PRINCIPAL DISPLAY PANEL

NDC 43553-3248-4

ConvaTec

ALOE VESTATM

Skin Conditioner 2

MOISTURIZE

SKIN PROTECTANT

Dermatologist Recommended

Fragrance Free

Softens

Moisturizes

NET WT. 4 fl.oz.(118mL)

Case Order No. 324804

ALOE VESTA SKIN CONDITIONER 
skin conditioner lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-3248
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE.03 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
GLYCERIN 
STEARETH-2 
CETYL ALCOHOL 
BENZYL ALCOHOL 
LAURETH-23 
MAGNESIUM ALUMINUM SILICATE 
CARBOMER 934 
POTASSIUM SORBATE 
SODIUM HYDROXIDE 
ALOE VERA LEAF 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43553-3248-259 mL in 1 BOTTLE
2NDC:43553-3248-4118 mL in 1 BOTTLE
3NDC:43553-3248-9236 mL in 1 BOTTLE
4NDC:43553-3248-13992 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/15/1998
Labeler - ConvaTec, Inc. (947989757)
Registrant - ConvaTec, Inc. (947989757)
Establishment
NameAddressID/FEIOperations
Guest Packaging LLC001773076manufacture
Establishment
NameAddressID/FEIOperations
Medicia091396697manufacture
Establishment
NameAddressID/FEIOperations
ConvaTec, Inc.947989757analysis

Revised: 04/2011
Document Id: 9318e568-74d8-4589-84da-f76131ecbf2c
Set id: 9838019c-79ea-440d-9ee0-7286294f2b24
Version: 2
Effective Time: 20110414
 
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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