Label: SENSI CARE MOISTURIZING BODY- petrolatum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated April 14, 2011

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  • Active Ingredients

    Petrolatum 30%

    Dimethicone 1%

  • Purpose

    Skin Protectant

    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 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 cream 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, 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

  • INGREDIENTS AND APPEARANCE
    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
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