HAND ESSENTIALS SKIN REPAIR- dimethicone cream

Hand Essentials Skin Repair by

Drug Labeling and Warnings

Hand Essentials Skin Repair by is a Otc medication manufactured, distributed, or labeled by HU-FRIEDY MFG. CO., INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

HAND ESSENTIALS SKIN REPAIR 
dimethicone cream

Product 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)