WORKMANS FRIEND SUPERIOR BARRIER SKIN- dimethicone cream

WORKMANS FRIEND SUPERIOR BARRIER SKIN by

Drug Labeling and Warnings

WORKMANS FRIEND SUPERIOR BARRIER SKIN by is a Otc medication manufactured, distributed, or labeled by SolvChem, Inc., PACKAGING SERVICE CO., INC., Vitacare Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

DIMETHICONE (DIMETHICONOL) 1%

PURPOSE

SKIN PROTECTANT

USES

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

For external use only. If swallowed, do NOT induce vomiting. Rinse mouth with water. If symptoms develop seek medical attention. When using this product, do not get into eyes. If in contact with eyes flush with water. 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.

DIRECTIONS

Shake well before use. Clean and dry hands and skin. Apply Workman's Friend™ Barrier Skin Cream to the palm of hand and rub thoroughly into hands and skin, making sure front and back of hands, including cuticles, are completely covered. Allow to dry for 3-5 minutes or until completely absorbed into skin. Severely cracked skin may sting once cream is applied. This is normal. If excessive stinging or rash occurs or worsens, discontinue use.

Other:

STORE IN A COOL PLACE AWAY FROM DIRECT SUNLIGHT

Inactive Ingredients:

Deionized Aqua/Water, Stearic Acid, Propylene Glycol, Glyceryl Stearate, Isopropyl Palmitate, Ricinus Communis (Castor) Seed Oil, Cyclopentasiloxane, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Mineral Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Xanthan Gum, Disodium EDTA, Acrylates Copolymer, Aloe Barbadensis Leaf Extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WORKMANS FRIEND SUPERIOR BARRIER SKIN 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71810-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CASTOR OIL (UNII: D5340Y2I9G)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71810-101-13	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2017
2	NDC: 71810-101-11	3 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/30/2017

Labeler - PACKAGING SERVICE CO., INC. (008435950)

Registrant - PACKAGING SERVICE CO., INC. (008435950)

Establishment
Name	Address	ID/FEI	Business Operations
Vitacare Labs Inc.		244187550	manufacture(71810-101)