Hand Essentials Skin Repair

Dosage form: cream
Ingredients: DIMETHICONE 1.5mL in 100mL
Labeler: HU-FRIEDY MFG. CO., INC.
NDC Code: 65626-161

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 Facts

Active ingredient

Dimethicone 1.5%

Purpose

Skin protectant

Uses
  • Temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

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
  • Apply cream liberally as needed.

Other information
  • Protect from freezing. Avoid excessive heat.

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

Every Day Moisturizer

with Olivamine

  • Nourishes and conditions dry, cracked skin
  • Non-allergenic
  • Non-sensitizing
  • CHG & latex friendly

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ASCORBIC ACID 
ASCORBYL PALMITATE 
CANOLA OIL 
CETYL ALCOHOL 
CHOLECALCIFEROL 
CITRIC ACID MONOHYDRATE 
ORANGE OIL 
MANDARIN OIL 
DIAZOLIDINYL UREA 
GLYCERIN 
GLYCERYL MONOSTEARATE 
GLYCINE 
PROLINE 
TAURINE 
METHYLPARABEN 
DIMETHYL SULFONE 
ACETYLCYSTEINE 
NIACINAMIDE 
OLIVE OIL 
POLYETHYLENE GLYCOL 400 
PEG-100 STEARATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
PYRIDOXINE HYDROCHLORIDE 
VITAMIN A PALMITATE 
STEARIC ACID 
STEARYL ALCOHOL 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL 
TROLAMINE 
VANILLIN 
WATER 
CORN OIL 
Packaging
#Item CodePackage Description
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 PACKET 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: 03/2012
 
HU-FRIEDY MFG. 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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