NDC | 71810-101-11, 71810-101-13 |
Set ID | da12ac2c-1af9-47b1-aa5f-77acb48535ba |
Category | HUMAN OTC DRUG LABEL |
Packager | PACKAGING SERVICE CO., INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- ACTIVE INGREDIENT(S)
- PURPOSE
- USES
- KEEP OUT OF REACH OF CHILDREN
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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.
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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:
-
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
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INGREDIENTS AND APPEARANCE
WORKMANS FRIEND SUPERIOR BARRIER SKIN
dimethicone creamProduct 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)