DRUG FACTS:

ACTIVE INGREDIENTS:

Dimethicone 5.00%

Skin Protectant

USES:

Temporarily protects and helps relieve chapped or cracked skin

WARNINGS:

For external use only.
Avoid contact with eyes.

Stop use and ask a doctor

if condition worsens or 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 or serious burns.

Keep out of reach of children.

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

DIRECTIONS (Adults and Children Over 12 Years):

Cleanse the affected area and allow to dry. Apply as needed.

INACTIVE INGREDIENTS:

Aqua (Deionized Water), Aloe Barbadensis (Aloe Vera Gel) Juice, Glyceryl Stearate, PEG-100 Stearate, Carthamus Tinctorius (Sunflower) Oil, Stearic Acid, Cetyl Alcohol, Butylene Glycol, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Zingiber Officinale (Ginger) Extract, Pyridoxine HCL (Vitamin B6), Pantothenic Acid (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Disodium EDTA, Silica, Triethanolamine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin.

Package Labeling:

Label

SCARZEN
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71574-500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
HYALURONIC ACID (UNII: S270N0TRQY)
GINGER (UNII: C5529G5JPQ)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
PANTOTHENIC ACID (UNII: 19F5HK2737)
SAFFLOWER (UNII: 4VBL71TY4Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71574-500-72	1 in 1 BOX	08/01/2018
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	08/01/2018

Labeler - Village Pharma LLC (080749749)

Scarzen (Dimethicone 5%)