Label: CLOROX CARECONCEPTS BED BATH AND HYGIENE- kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated August 21, 2014

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  • Active Ingredient 

    Dimethicone 1.25 percent

  • Purpose

    Skin Protectant

  • Use

    • Helps prevent and temporarily protect dry, cracked, chafed skin.
  • Warnings

    For external use only

  • WHEN USING

    When using this product do not get into eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply liberally as often as needed.
  • Inactive Ingredients

    Water, Mineral Oil, Propylene Glycol, Glyceryl Distearate, Glyceryl Stearate, Microcrystalline Wax, Cetyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrahydroxypropyl Ethylenediamine, Phenoyethanol, Fragrance, Methylparaben, Benzatriazoyl Dodecyl p-Cresol, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben

  • Active ingredient

    Alcohol 67 percent

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to decrease bacteria on the skin that potentially can cause disease

  • Warnings

    Flammable. Keep away from fire or flame.
    For external use only.

  • WHEN USING

    When using this product, do not use in the eyes.

  • STOP USE

    Discontinue use and ask a doctor if

    • irritate and redness develop.
    • condition persists for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other Information

    Store in a cool, dry place below 104 deg F (40 deg C).

  • Inactive ingredients

    Water, Isopropyl Alcohol, Glycerin, Glyceryl Laurate.

  • PRINCIPAL DISPLAY PANEL

    BedBathHygKitClorox Care Concepts
    Bed Bath and Hygiene Kit
    Nitrile Non-Latex Exam Gloves
    No-Rinse Shampoo
    Hand Sanitizer
    Bathing Wipes
    Aloe Moisturizing Lotion Skin Protectant

  • INGREDIENTS AND APPEARANCE
    CLOROX CARECONCEPTS BED BATH AND HYGIENE 
    patient personal hygiene kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NHRIC:26509-0007
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:26509-0007-11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 PACKAGE 1 
    Part 21 TUBE 118 mL
    Part 31 BOTTLE, SPRAY 59 mL
    Part 41 BOTTLE, PUMP 236 mL
    Part 51 PACKAGE 155 g
    Part 1 of 5
    NITRILE NON-LATEX GLOVES 
    patient examination glove
    Product Information
    Item Code (Source)GS1:8438995971
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK05137804/07/2014
    Part 2 of 5
    CLOROX CARECONCEPTS ALOE MOISTURIZING 
    dimethicone lotion
    Product Information
    Item Code (Source)NDC:26509-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.25 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    glycerin (UNII: PDC6A3C0OX)  
    aloe (UNII: V5VD430YW9)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EDETOL (UNII: Q4R969U9FR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1NDC:26509-0009-1118 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/07/2014
    Part 3 of 5
    CLOROX CARE CONCEPTS HAND SANITIZER 
    alcohol solution
    Product Information
    Item Code (Source)NDC:26509-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26509-0002-159 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2014
    Part 4 of 5
    CLOROX CARECONCEPTS NO-RINSE SHAMPOO 
    shampoos (non-coloring)
    Product Information
    Item Code (Source)GS1:4460031084
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 5 of 5
    CLOROX CARECONCEPTS BATHING WIPES 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Item Code (Source)GS1:4460031072
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1155 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceABC04/07/2014
    Labeler - The Clorox Company (009138033)
    Registrant - The Clorox Company (009138033)
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