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Product NDC Code | 39765-008 | ||||||
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Drug Name | Heeltastic |
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Type | Brand | ||||||
Pharm Class | Skin Barrier Activity [PE] | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | STICK | ||||||
RxCUI drug identifier | 198604 | ||||||
Application Number | part347 | ||||||
Labeler Name | Neutraderm, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Dimethicone(1%)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply as needed. Children under 2 years, ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses helps to relieve cracking and chapping temporarily protects cracked skin
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Heeltastic DIMETHICONE DIMETHICONE DIMETHICONE COCONUT OIL HYDROGENATED SOYBEAN OIL YELLOW WAX CARNAUBA WAX CERESIN AZADIRACHTA INDICA SEED OIL KARUM SEED OIL NIGELLA SATIVA SEED OIL SHEA BUTTER COCOA BUTTER ISOPROPYL MYRISTATE RICE BRAN OIL OLIVE OIL AVOCADO OIL ALMOND OIL SAFFLOWER OIL SUNFLOWER OIL TOLNAFTATE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE PHENOXYETHANOL CAPRYLYL GLYCOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Intensive Heel Therapy Watch dry cracked heels disappear
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API