ALOE VESTA SKIN CONDITIONER - skin conditioner lotion 
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

Dimethicone 3%

Purpose

Skin Protectant

Uses

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:

For diaper rash:

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

Aloe Vesta Skin Conditioner Label

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE.03 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARETH-2 (UNII: V56DFE46J5)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LAURETH-23 (UNII: N72LMW566G)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
CARBOMER 934 (UNII: Z135WT9208)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Guest Packaging LLC001773076manufacture
Establishment
NameAddressID/FEIBusiness Operations
Medicia091396697manufacture
Establishment
NameAddressID/FEIBusiness Operations
ConvaTec, Inc.947989757analysis

Revised: 4/2011
Document Id: 9318e568-74d8-4589-84da-f76131ecbf2c
Set id: 9838019c-79ea-440d-9ee0-7286294f2b24
Version: 2
Effective Time: 20110414
 
ConvaTec, Inc.