Label: SENSI CARE BODY CREAM- petrolatum, dimethicone 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 June 18, 2016

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  • Drug Facts

  • 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

    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.

  • Active ingredients

    Petrolatum 30%

    Dimethicone 1%

  • Purpose

    Skin Protectant

  • Inactive ingredients

    Water, Glycerin, Cetyl Alcohol, Propylene Glycol Diethylhexanoate, Steareth-2, PVP/Hexadecene Copolymer, Laureth-23, Magnesium Aluminum Silicate, Carbomer, Diazolidinyl Urea, Sodium Hydroxide, Methyl chloroisothiazolinone, Methyl isothiazolinone, Magnesium Chloride, Magnesium Nitrate

  • STORAGE AND HANDLING

    Other information Store at 15°C -30°C (59°F - 86°F)

  • SPL UNCLASSIFIED SECTION

    SENSI-CARE TM

    BODY CREAM

    - Skin Protectant

    - CHG Compatible

    - Relieves Chronic Dry Skin

    - Fragrance & Dye Free

    - Clear In Use

    - For All Ages

    Manufactured for:
    ConvaTec

    ConvaTec Inc.
    Greensboro, NC 27409
    1-800-422-8811
    www.convatec.com

    Made in USA

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    SENSI CARE BODY CREAM 
    petrolatum, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11099-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM25.5 g  in 85 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE850 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
    STEARETH-2 (UNII: V56DFE46J5)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    LAURETH-23 (UNII: N72LMW566G)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11099-0002-385 g in 1 TUBE; Type 0: Not a Combination Product06/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/09/2016
    Labeler - Guest Packaging LLC. (001773076)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guest Packaging LLC.001773076manufacture(11099-0002)
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