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WORKMANS FRIEND SUPERIOR BARRIER SKIN

Dosage form: cream
Ingredients: DIMETHICONE 1g in 100mL
Labeler: PACKAGING SERVICE CO., INC.
NDC Code: 71810-101

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.

WORKMAN'S FRIEND SUPERIOR BARRIER SKIN CREAM

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.

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.

WORKMANS FRIEND SUPERIOR BARRIER SKIN 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71810-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
STEARIC ACID 
PROPYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
ISOPROPYL PALMITATE 
CASTOR OIL 
CYCLOMETHICONE 5 
MINERAL OIL 
PHENOXYETHANOL 
JOJOBA OIL 
SODIUM HYDROXIDE 
ETHYLHEXYLGLYCERIN 
XANTHAN GUM 
ALOE VERA LEAF 
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) 
Packaging
#Item CodePackage Description
1NDC:71810-101-13100 mL in 1 BOTTLE
2NDC:71810-101-113 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/30/2017
Labeler - PACKAGING SERVICE CO., INC. (008435950)
Registrant - PACKAGING SERVICE CO., INC. (008435950)
Establishment
NameAddressID/FEIOperations
Vitacare Labs Inc.244187550manufacture(71810-101)

Revised: 12/2017
 
PACKAGING SERVICE CO., INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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