Label: HAND ESSENTIALS SKIN REPAIR- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65626-161-04, 65626-161-13, 65626-161-23, 65626-161-96 - Packager: HU-FRIEDY MFG. CO., INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 29, 2012
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Canola Oil, Cetyl Alcohol, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycerin, Glyceryl Stearate SE, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8, PEG-100 Stearate, Propylene Glycol, Propylparaben, Pyridoxine HCI, Retinyl Palmitate, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vanillin, Water, Zea Mays Oil.
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INGREDIENTS AND APPEARANCE
HAND ESSENTIALS SKIN REPAIR
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65626-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) CANOLA OIL (UNII: 331KBJ17RK) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLECALCIFEROL (UNII: 1C6V77QF41) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE OIL (UNII: AKN3KSD11B) MANDARIN OIL (UNII: NJO720F72R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCINE (UNII: TE7660XO1C) PROLINE (UNII: 9DLQ4CIU6V) TAURINE (UNII: 1EQV5MLY3D) METHYLPARABEN (UNII: A2I8C7HI9T) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) NIACINAMIDE (UNII: 25X51I8RD4) OLIVE OIL (UNII: 6UYK2W1W1E) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TROLAMINE (UNII: 9O3K93S3TK) VANILLIN (UNII: CHI530446X) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65626-161-23 946 mL in 1 BOTTLE, PUMP 2 NDC:65626-161-13 59 mL in 1 TUBE 3 NDC:65626-161-04 118 mL in 1 TUBE 4 NDC:65626-161-96 144 in 1 CARTON 4 4 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/01/2010 Labeler - HU-FRIEDY MFG. CO., INC. (005085972)