MIRACLE HEEL REPAIR- allantoin , dimethicone cream

Miracle Heel Repair by

Drug Labeling and Warnings

Miracle Heel Repair by is a Otc medication manufactured, distributed, or labeled by Winning Solutions, Beautymanufacturing Solutions Corperation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Allantoin 1.0 % , Dimethicone 1.0 %

PURPOSE

Purpose : Skin Protectant

WARNINGS

Warnings: For external use only .

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

Directions :  adults and  children 2 years and older apply as needed

                      under 2 years ask a doctor.

                      wash and dry skin apply liberatly over attached area and massage until absorbed .

INDICATIONS & USAGE

Uses: Temporary protects and helps relieve chapped or cracked skin

INACTIVE INGREDIENT

aloe barabardensis leaf Juice , water , PEG 8, stearic acid , PEG-100 stearte , glyceryl stearate , cetearyl alcohol, polysorbate 60 , propylene glycol, mineral oil ,hydrogenated polyisobutene,cetyl alcohl , butyrospermum parkii (shea butter) , theobroma cacao (cocoa) seed butter , triethanolamine, mangifera indica (mango) seed butter, salicylic acid ,chondrus crispis (carageenan) , arthemis nobilis flower extract, fragrance, methylparaben, propylparaben,  tetrasodium edta , bht, diazolidinyl urea

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

MIRACLE HEEL REPAIR  
allantoin , dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66391-0604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	1.12 g  in 112 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1.12 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Stearic Acid (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
Mineral Oil (UNII: T5L8T28FGP)
Cetyl Alcohol (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
TROLAMINE (UNII: 9O3K93S3TK)
MANGO (UNII: I629I3NR86)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CHONDRUS (UNII: XR12Z4HLEA)
CHAMOMILE (UNII: FGL3685T2X)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66391-0604-0	112 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	03/16/2009

Labeler - Winning Solutions (962718300)

Registrant - Beautymanufacturing Solutions Corperation (783200723)