Your browser does not support JavaScript! GENRX ALL PURPOSE CLEANSING (DIMETHICONE) LOTION [PURETEK CORPORATION]
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GENRX ALL PURPOSE CLEANSING (dimethicone) lotion
[PureTek Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Dimethicone 1.75%

Purpose

Skin Protectant

Uses

■ temporarily protects and helps relieve chapped or cracked skin
■ cleanses, moisturizes, nourishes, and protects skin
■ it can be used on face, body and perineal area

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 recur 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 cleanser to damp cloth or to skin/perineal area
■ gently wipe clean (no rinsing necessary)
■ apply as needed
■ apply GenRx protectant cream or paste as necessary

Other information

■ protect from freezing    ■ avoid excessive heat

Inactive ingredients

Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, caprylyl glycol, cetyl alcohol, chlorphenesin, disodium EDTA, fragrance, glycerin, Glycine soja (soybean) oil, glyceryl stearate, 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], linoleamidopropyl PG-dimonium chloride phosphate, PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

All Purpose Cleansing Lotion with GenRx Complex​TM (8 oz bottle label)

GenRx All Purpose Cleansing Lotion 8 oz image

GENRX ALL PURPOSE CLEANSING 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59088-644
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone17.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
KUKUI NUT OIL 
ALOE VERA LEAF 
BUTYLENE GLYCOL 
CAPRYLYL GLYCOL 
CETYL ALCOHOL 
CHLORPHENESIN 
EDETATE DISODIUM 
GLYCERIN 
SOYBEAN OIL 
GLYCERYL MONOSTEARATE 
LEVOMENOL 
CALCIUM PANTOTHENATE 
CARTHAMUS TINCTORIUS SEED OLEOSOMES 
MALTODEXTRIN 
NIACINAMIDE 
PYRIDOXINE HYDROCHLORIDE 
SILICON DIOXIDE 
SODIUM ASCORBYL PHOSPHATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINGER 
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
PEG-100 STEARATE 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
PHENOXYETHANOL 
WATER 
HYALURONATE SODIUM 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-644-16237 mL in 1 BOTTLE, PLASTIC
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(59088-644), pack(59088-644), label(59088-644)

Revised: 1/2013
 
PureTek Corporation

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