Active Ingredient

Dimethicone 1%..............................Skin Protectant

Purpose

Skin Protectant

Uses

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

For external use only.

When using this product

do not get into the eyes

Stop use and ask physician if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

Other information

Store at 20° – 25°C (68° – 77°F).

Inactive Ingredients

Water, Propanediol, Ricinus Communis (Castor) Seed Oil, Lauryl Laurate, Arachidyl Alcohol, Inula Viscosa Flower/Leaf/Stem Extract, Stearyl Alcohol, Behenyl Alcohol, Glycerin, Synthetic Beeswax, Arachidyl Glucoside, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Limonene, Sodium Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Sorbate, Disodium EDTA, Xanthan Gum, Hydrolyzed Vegetable Protein, Citrus Aurantium Dulcis (Orange) Peel Oil, Leuconostoc/Radish Root Ferment Filtrate, Linalool, Citral

Questions?

Call toll free 1-844-474-2552 or visit www.lavior.com

Diabetic Foot Cream

DIABETIC FOOT CREAM
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71521-392
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
LAURYL LAURATE (UNII: GPW77G0937)
GLYCERIN (UNII: PDC6A3C0OX)
CASTOR OIL (UNII: D5340Y2I9G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
XANTHAN GUM (UNII: TTV12P4NEE)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PROPANEDIOL (UNII: 5965N8W85T)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
DOCOSANOL (UNII: 9G1OE216XY)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ORANGE OIL (UNII: AKN3KSD11B)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71521-392-10	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	03/31/2021

Labeler - Lavior Pharma Inc (080685327)