Drug Facts

Active ingredients (in cream)

Dimethicone 1%

Purpose

Skin protectant

Uses

Helps prevent, relieve, and temporarily protects chafed, chapped, or cracked skin
Heps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Keep out of reach of children

When using this product

do not get into eyes

Stop use and ask a doctor 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

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

Directions

Apply as needed

Inactive ingredients

Water (Aqua), Canola Oil, Ethylhexyl Stearate, Propylene Glycol, Beeswax, Tocopheryl Acetate, Ceteth-20, Cetyl Alcohol, Steareth-10, Steareth-21, Carbomer, Oleyl Lactate, Glyceryl Stearate, Stearic Acid, Phenoxyethanol, PEG-100 Stearate, Glycerin, Sodium Hydroxide, Citrullus Lanatus (Watermelon) Fruit Extract, Benzoic Acid, Urea, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Sorbic Acid, Sodium Lactate, Sodium PCA, Sea Salt, Plakton Extract, Ethyl Linoleate, Cucumis Sativus (Cucumber) Fruit Extract

Package Labels:

Box Jar

DIABETICS DRY SKIN RELIEF
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43689-0024
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CANOLA OIL (UNII: 331KBJ17RK)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-10 (UNII: FD0913P475)
STEARETH-21 (UNII: 53J3F32P58)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
OLEYL LACTATE (UNII: B3AWW0N3GM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATERMELON (UNII: 231473QB6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
UREA (UNII: 8W8T17847W)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
APPLE (UNII: B423VGH5S9)
SORBIC ACID (UNII: X045WJ989B)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SEA SALT (UNII: 87GE52P74G)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
CUCUMBER (UNII: YY7C30VXJT)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43689-0024-1	113 g in 1 JAR; Type 0: Not a Combination Product	05/12/2017
2	NDC:43689-0024-2	1 in 1 BOX	05/12/2017
2		113 g in 1 JAR; 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	05/12/2017

Labeler - The Magni Group Inc (113501902)

Diabetics Dry Skin Relief

​Drug Facts

​Active ingredients (in cream)

​Purpose

​Uses

​Warnings