HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]

HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]
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NDC 65626-161-04, 65626-161-13, 65626-161-23, 65626-161-96
Set ID e3ed1718-8e24-44e6-a790-18723c426ac2
Category HUMAN OTC DRUG LABEL
Packager HU-FRIEDY MFG. CO., INC.
Generic Name
Product Class
Product Number
Application Number PART347
  • Active ingredient

    Dimethicone 1.5%

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.
  • Warnings

    For External Use Only.

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns

    When using this product

    • do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for 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 contact a Poison Control Center right away.
  • Directions

    • Apply cream liberally as needed.
  • Other information

    • Protect from freezing. Avoid excessive heat.
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Canola Oil, Cetyl Alcohol, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycerin, Glyceryl Stearate SE, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8, PEG-100 Stearate, Propylene Glycol, Propylparaben, Pyridoxine HCI, Retinyl Palmitate, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vanillin, Water, Zea Mays Oil.

  • Package/Label Principal Display Panel

    Hu-Friedy Hand Essentials Skin Repair Cream

    Hu-Friedy

    HAND ESSENTIALS

    Skin Repair Cream

    Every Day Moisturizer

    with Olivamine

    • Nourishes and conditions dry, cracked skin
    • Non-allergenic
    • Non-sensitizing
    • CHG & latex friendly

    Part-code: IMS-1502

    Hu-Friedy

    2 Fl oz (59 mL)

  • INGREDIENTS AND APPEARANCE
    HAND ESSENTIALS SKIN REPAIR 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65626-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    MANDARIN OIL (UNII: NJO720F72R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCINE (UNII: TE7660XO1C)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    TAURINE (UNII: 1EQV5MLY3D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65626-161-23946 mL in 1 BOTTLE, PUMP
    2NDC:65626-161-1359 mL in 1 TUBE
    3NDC:65626-161-04118 mL in 1 TUBE
    4NDC:65626-161-96144 in 1 CARTON
    44 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2010
    Labeler - HU-FRIEDY MFG. CO., INC. (005085972)

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