Label: SALLY HANSEN CRACKED HEEL REPAIR CREME 24 HR MOISTURE- dimethicone cream

  • NDC Code(s): 66184-152-01, 66184-152-02
  • Packager: Coty US LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • Active Ingredient


    Dimethicone 1%

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  • Purpose

    Skin protectant

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  • Keep out of reach of children

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

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  • Uses

    Temporarily protects chapped or cracked skin

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  • Warnings

    For external use only

    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
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  • Directions

    Apply and massage into feet daily, or as needed.

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  • Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
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  • Inactive Ingredients

    Aqua/Water/Eau, Paraffinum Liquidum/Mineral Oil/Huile Minerale, Carthamus Tinctorius (Safflower) Seed Oil, Petrolatum, Palmitic Acid, Stearic Acid, Glycerin, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Isopropyl Lanolate, Isopropyl Palmitate, Sorbitan Stearate, Phenoxyethanol, Parfum/Fragrance, Potassium Hydroxide, Methylparaben, Tocopheryl Acetate, Allantoin, Urea, Disodium Edta, Propylparaben, C12-15 Alkyl Benzoate, Limonene, Myristic Acid, Lineoleamidopropyl PG-Dimonium Chloride Phosphate, Sodium PCA, Ethylparaben, Propylene Glycol, Tribehenin, Linalool, Hydrolyzed Keratin, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Hexyl Cinnamal, Butylphenyl Methylpropinoal, Glycine Soja (Soybean) Seed Extract, Sodium Sulfate, Citral, Ceramide 2, Aloe Barbadensis Leaf Extract, Soluble Collagen, Coumarin, PEG-10 Rapeseed Sterol, Geraniol, Citronellol, Imdazolidnyl Urea, Potassium Sorbate, Benzoic Acid, Sodium Benzoate, Tocopherol, BHT, Palmitoyl Oligopeptide, FD&C Yello No. 5, FD&C Yello N

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  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN CRACKED HEEL REPAIR CREME  24 HR MOISTURE
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-152
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.133 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SHEANUT OIL (UNII: O88E196QRF)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    UREA (UNII: 8W8T17847W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 7461U1YLB7)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Citral (UNII: T7EU0O9VPP)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COUMARIN (UNII: A4VZ22K1WT)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66184-152-02 1 in 1 BOX
    1 NDC:66184-152-01 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 01/01/2012
    Labeler - Coty US LLC (789573201)
    Establishment
    Name Address ID/FEI Business Operations
    Process Technologies and Packaging Inc. 809172885 manufacture(66184-152)
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