NURTURE BARRIER- dimethicone cream 
Rise Global Products

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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Active Ingredient                        Purpose

Dimethicone 5%................Skin Protectant

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

Keep out of reach of children

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

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

When using this product

Stop use and ask a doctor if

Directions

Other Information

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.

label image

NURTURE BARRIER 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59973-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
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)  
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)  
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
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)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59973-001-01118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2012
Labeler - Rise Global Products (078587681)
Establishment
NameAddressID/FEIBusiness Operations
Omega Packaging361281991manufacture(59973-001)

Revised: 8/2013
Document Id: 8d1e32c4-dbee-48e9-bc34-4c9934d9f998
Set id: d6cee57f-5252-4d5f-b7a4-3ed344ffe213
Version: 4
Effective Time: 20130816
 
Rise Global Products