MIRACLE HEEL REPAIR - allantoin , dimethicone cream
Winning Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient : Allantoin 1.0 % , Dimethicone 1.0 %

Purpose : Skin Protectant

Warnings: For external use only .

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

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 .

Uses: Temporary protects and helps relieve chapped or cracked skin

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

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MIRACLE HEEL REPAIR
allantoin , dimethicone cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Winning Solutions (962718300)

Registrant - Beautymanufacturing Solutions Corperation (783200723)