NURTURE SKIN PROTECTANT- dimethicone cream

Nurture Skin Protectant by

Drug Labeling and Warnings

Nurture Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Rise Global Products, Omega Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                        Purpose

Dimethicone 1.0%..............Skin Protectant

PURPOSE

Long-lasting nourishing formula that helps prevent dry, cracked skin.

• Non-Sensitizing
• Non-Allergenic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INDICATIONS & USAGE

Uses

Temporarily protects and helps relieve chapped or cracked skin. 

Beneficial for face, hands, body and legs

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

• Cleanse skin with Nurture(TM) Foaming Body Cleanser
• Apply cream liberally to affected area as needed

OTHER SAFETY INFORMATION

Other Information

• Protect from freezing
• Avoid excessive heat

INACTIVE INGREDIENT

Inactive Ingredients

Water, canola oil, alow barbadensis leaf juice, PEG-8, glyceryl stearate, glycerin, propylene glycol, cyclomethicone, cetyl alcohol, stearic acid, triethanolamine, PEG-100 Stearate, allantoin, pyridoxine HCL, niacinamide, glycine, L-taurine, N-acetyl-L-cysteine, methylsulfonylmethane, L-proline, vanillin, citrus aurantium dulcis (orange) peel oil, citrus tangerina (tangerine) peel oil, citrus grandis (grapefruit) peel oil, dimethicone/vinyl dimethicone crosspolymer, citric acid, urea, polymethylsilsesquioxane, ammonium acryloyldimethyl taurate/vp copolymer, phenoxyethanol, DMDM hydantoin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NURTURE SKIN PROTECTANT 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59973-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SESAME OIL (UNII: QX10HYY4QV)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE OIL (UNII: AKN3KSD11B)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
MANDARIN OIL (UNII: NJO720F72R)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCINE (UNII: TE7660XO1C)
PROLINE (UNII: 9DLQ4CIU6V)
TAURINE (UNII: 1EQV5MLY3D)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
VANILLIN (UNII: CHI530446X)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59973-002-01	118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2012

Labeler - Rise Global Products (078587681)

Establishment
Name	Address	ID/FEI	Business Operations
Omega Packaging		361281991	manufacture(59973-002)