HAND ESSENTIALS SKIN REPAIR- dimethicone cream 
HU-FRIEDY MFG. CO., INC.

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.

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Drug Facts

Active ingredient

Dimethicone 1.5%

Purpose

Skin protectant

Uses

Warnings

For External Use Only.

Do not use

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

When using this product

  • do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

Other information

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.

Package/Label Principal Display Panel

Hu-Friedy Hand Essentials Skin Repair Cream

Hu-Friedy

HAND ESSENTIALS

Skin Repair Cream

Every Day Moisturizer

with Olivamine

Part-code: IMS-1502

Hu-Friedy

2 Fl oz (59 mL)

HAND ESSENTIALS SKIN REPAIR 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65626-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65626-161-23946 mL in 1 BOTTLE, PUMP
2NDC:65626-161-1359 mL in 1 TUBE
3NDC:65626-161-04118 mL in 1 TUBE
4NDC:65626-161-96144 in 1 CARTON
44 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2010
Labeler - HU-FRIEDY MFG. CO., INC. (005085972)

Revised: 3/2012
Document Id: d102e331-fd3f-46ca-9382-2f103afbc853
Set id: e3ed1718-8e24-44e6-a790-18723c426ac2
Version: 2
Effective Time: 20120329
 
HU-FRIEDY MFG. CO., INC.