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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59088-851
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
KUKUI NUT OIL 
ALOE VERA LEAF 
C12-13 PARETH-23 
C12-13 PARETH-3 
SAFFLOWER OIL 
CYCLOMETHICONE 5 
DICAPRYLYL CARBONATE 
DIMETHICONOL (40 CST) 
LEVOMENOL 
CALCIUM PANTOTHENATE 
CARTHAMUS TINCTORIUS SEED OLEOSOMES 
MALTODEXTRIN 
NIACINAMIDE 
PYRIDOXINE HYDROCHLORIDE 
SILICON DIOXIDE 
SODIUM ASCORBYL PHOSPHATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINGER 
PEG/PPG-18/18 DIMETHICONE 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
PROPYLHEPTYL CAPRYLATE 
WATER 
SODIUM CHLORIDE 
HYALURONATE SODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-851-69144 in 1 CARTON
1NDC:59088-851-014 mL in 1 POUCH
2NDC:59088-851-0559 mL in 1 TUBE
3NDC:59088-851-08118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/08/2013
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046manufacture(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