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NDC 39765-0008-01 Heeltastic 1 g/100g Details

Heeltastic 1 g/100g

Heeltastic is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Neutraderm, Inc.. The primary component is DIMETHICONE.

Product Information

NDC	39765-0008
Product ID	39765-008_3f6d4a90-5c86-4874-b63a-a48f9aea44b7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Heeltastic
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIMETHICONE
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	DIMETHICONE
Labeler Name	Neutraderm, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 39765-0008-01 (39765000801)

Pricing Information	N/A
NDC Package Code	39765-008-01
Billing NDC	39765000801
Package	57 g in 1 BOTTLE (39765-008-01)
Marketing Start Date	2009-06-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d08778d6-f5f2-4187-b82e-ef1e6afae077 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/30/2009

Labeler - Neutraderm, Inc. (146224444)

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

Revised: 11/2018

Document Id: 3f6d4a90-5c86-4874-b63a-a48f9aea44b7

Set id: d08778d6-f5f2-4187-b82e-ef1e6afae077

Version: 4

Effective Time: 20181102