GENRX SKIN BARRIER- dimethicone cream 
PureTek Corporation

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

Dimethicone 1.5%

Purpose

Skin Protectant

Uses

■ for the treatment and/or prevention of diaper rash
■ temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

Do not use on

■ deep or puncture wounds    ■ animal bites    ■ serious burns

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens
■ symptoms last 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 liberally as needed

Other information

■ protect from freezing    ■ avoid excessive heat

Inactive ingredients

Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, C12-13 pareth-23, C12-13 pareth-3, Carthamus tinctorius (safflower) seed oil, cetyl dimethicone, cyclopentasiloxane, dicaprylyl carbonate, dimethiconol, divinyldimethicone/dimethicone copolymer, fragrance, GenRx Complex™ [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG/PPG-18/18 dimethicone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, propylene glycol, propylheptyl caprylate, purified water, sodium chloride, sodium hyaluronate.

Skin Barrier Cream with GenRx Complex​TM (4 oz tube label)

GenRx Skin Barrier Cream 4 oz image

GENRX SKIN BARRIER 
dimethicone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-851
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 15 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
C12-13 PARETH-23 (UNII: J1WW1510L4)  
C12-13 PARETH-3 (UNII: DMC6N3419L)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GINGER (UNII: C5529G5JPQ)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59088-851-69 144 in 1 CARTON
1 NDC:59088-851-01 4 mL in 1 POUCH
2 NDC:59088-851-05 59 mL in 1 TUBE
3 NDC:59088-851-08 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/08/2013
Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Business Operations
PureTek Corporation 785961046 manufacture(59088-851) , pack(59088-851) , label(59088-851)

Revised: 1/2013
Document Id: b0b80ff7-70de-4525-88e3-8f2a780999c6
Set id: 2224b5ed-9172-454a-a8c0-b21a008898a2
Version: 1
Effective Time: 20130131
 
PureTek Corporation