GENRX DAILY DEFENSE ANTIFUNGAL- miconazole nitrate 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

Miconazole Nitrate 2.0%

Purpose

Antifungal

Uses

■ for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
■ relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings

For external use only

Do not use on

children under 2 years of age unless directed by a doctor

When using this product

avoid contact with eyes

Stop use and ask a doctor if

■ for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
■ for jock itch - irritation occurs or there is no improvement within 2 weeks

Keep out of reach of children.

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

Directions

■ clean the affected area and dry thoroughly
■ apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
■ supervise children in the use of this product
■ for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
■ for athlete's foot and ringworm, use daily for 4 weeks
■ for jock itch, use daily for 2 weeks
■ if condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Other information

■ protect from freezing    ■ avoid excessive heat

Inactive ingredients

Aleurites moluccana seed oil, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, cetyl phosphate, chlorphenesin, dimethicone, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, 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], PEG-100 stearate, pentylene glycol, phenoxyethanol, purified water, sodium hyaluronate, sodium hydroxide, stearyl alcohol.

Daily Defense Antifungal Cream with GenRx Complex​TM (4 oz tube label)

GenRx Daily Defense Antifungal Cream 4 oz image

GENRX DAILY DEFENSE ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-746
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
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-100 STEARATE (UNII: YD01N1999R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59088-746-08 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 01/08/2013
Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Business Operations
PureTek Corporation 785961046 manufacture(59088-746) , pack(59088-746) , label(59088-746)

Revised: 1/2013
Document Id: 8f117e1c-6634-4c23-88eb-f13592490b93
Set id: 1eec15d1-e395-4353-97c2-6d786e35c80a
Version: 1
Effective Time: 20130125
 
PureTek Corporation