Label: HEELTASTIC- dimethicone stick

  • NDC Code(s): 39765-008-01, 39765-008-02
  • Packager: Neutraderm, Inc.
  • 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 November 2, 2018

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

View All Sections
  • Drug Facts

  • Active Ingredients

    Dimethicone(1%)

  • Purpose

    Skin Protectant

  • Uses

    • helps to relieve cracking and chapping
    • temporarily protects cracked skin
  • Warnings

    • For external use only
    • Do not use on: Deep or puncture wounds, animal bites, serious burns
    • When Using This Product avoid contact with eyes.
    • Stop Use and Ask a Doctor if condition worsens.

    Keep out of reach of children.

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

  • Directions

    • Apply as needed. Children under 2 years, ask a doctor.
  • Inactive Ingredients:

    Cocos Nucifera (Coconut) Fruit Oil, Glycine Soja (Soybean) Wax, Beeswax, Copernicia Cerifera (Carnauba) Wax, Ozokerite, Proprietary Blend of Essential Oils, Azadirachta Melia (Neem) Seed Oil, Pongamia Glabra (Karanja) Seed Oil, Nigella Sativa (Black Cumin) Seed Oil, Butyrospermum Parkii (Shea Butter), Theobroma Cacao (Cocoa) Seed Butter, Isopropyl Myristate, Oryza Sativa (Rice) Bran Oil, Olea  Europaea (Olive) Fruit Oil, Persea Gratissima (Avocado) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Seed Oil, Carthamus Tinctorious (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Tolnaftate, Tocopheryl Acetate, Retinyl Palmitate, Phenoxyethanol, Caprylyl Glycol

  • SPL UNCLASSIFIED SECTION

    Intensive Heel Therapy

    Watch dry cracked heels disappear

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HEELTASTIC  
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39765-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CERESIN (UNII: Q1LS2UJO3A)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOLNAFTATE (UNII: 06KB629TKV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39765-008-0157 g in 1 BOTTLE; Type 0: Not a Combination Product06/30/2009
    2NDC:39765-008-0228 g in 1 BOTTLE; Type 0: Not a Combination Product06/30/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/30/2009
    Labeler - Neutraderm, Inc. (146224444)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neutraderm, Inc.146224444manufacture(39765-008)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!