HEELTASTIC- dimethicone stick

Heeltastic by

Drug Labeling and Warnings

Heeltastic by is a Otc medication manufactured, distributed, or labeled by Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HEELTASTIC  
dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39765-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39765-008-01	57 g in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2009
2	NDC: 39765-008-02	28 g in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/30/2009

Labeler - Neutraderm, Inc. (146224444)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(39765-008)