SENSI CARE MOISTURIZING BODY - petrolatum cream 
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 Ingredients

Petrolatum 30%

Dimethicone 1%

Purpose

Skin Protectant

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, Glycerin, PG Dioctanoate, Cetyl Alcohol, Steareth-2, PVP/Hexadecene Copolymer, Laureth-23, Magnesium Aluminum Silicate, Diazolidinyl Urea, Carbomer, Sodium Hydroxide, Magnesium Nitrate, Methylchloroisothiazolinone and Methylisothiazolinone.

PRINCIPAL DISPLAY PANEL


Sensi Care Moisturizing Body Cream Label

NDC 43553-3244-3

ConvaTec

SENSI~CARETM

Moisturizing Body Cream 2

MOISTURIZE

SKIN PROTECTANT

Relieves Chronic Dry Skin

Fragrance Free

NET WT. 3oz.(85g)

CSX1083B  Case Order No. 324403

SENSI CARE MOISTURIZING BODY 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-3244
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM300 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARETH-2 (UNII: V56DFE46J5)  
LAURETH-23 (UNII: N72LMW566G)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CARBOMER 934 (UNII: Z135WT9208)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43553-3244-385 g in 1 TUBE
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: 5f94fd2e-b803-4b42-885d-f25cb63297db
Set id: 14e42630-c324-4d3c-921e-a60227690e10
Version: 3
Effective Time: 20110414
 
ConvaTec, Inc.