MAGIC HEAL- dimethicone stick

MAGIC HEAL by

Drug Labeling and Warnings

MAGIC HEAL by is a Otc medication manufactured, distributed, or labeled by PREMIER TRENDS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredients

Silicone Oil (Dimethicone) 1%

Purpose

Skin Protectant

Uses:

–Helps to soften and moisturize the skin

–Decrease itching and flaking

–Prevent dry, rough, scaly, and skin irritation

Warnings:

– For external use only

– Do not use on:

​Deep or puncture wounds, animal bites, serious burns

When Using This Product avoid contact with eye.

Stop Use and Ask a Doctor if condition worsens.

KEEP OUT OF REACH OF CHILDREN

– Keep out of reach of children.

Directions

– Apply as needed. Children under 2 years, ask a doctor.

Inactive Ingredients:

Azadirachta Indica (Neem) Seed Oil, Pongamia Glabra (Karanja) Oil, Vitamin E Oil, Cocoa Butter, Bee Wax, Shea Butter, Sunflower Seed Oil, Blend of Essential Oils.

SPL UNCLASSIFIED SECTION

Heel Therapy That Really Works

Cracked heels vanish like magic

Formulated in USA   MFG: Premier Trends LLC, Monroe Township, NJ 08831

CAUTION:

The application of Magic HeelTM to your feet may increase the chances of a slip and fall. Use extra care when walking on smooth surfaces with bare feet.

Packaging

INGREDIENTS AND APPEARANCE

MAGIC HEAL 
dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72168-786
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
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
KARUM SEED OIL (UNII: 62160PU6FJ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72168-786-12	1 in 1 BLISTER PACK	03/23/2018
1		57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/23/2018

Labeler - PREMIER TRENDS LLC (081105865)

Establishment
Name	Address	ID/FEI	Business Operations
PREMIER TRENDS LLC		081105865	manufacture(72168-786)