Label: GENRX DAILY DEFENSE ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 59088-746-08
- Packager: PureTek Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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%Close
■ for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)Close
■ relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
For external use only
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.
■ clean the affected area and dry thoroughlyClose
■ 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 heatClose
- 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.Close
- Daily Defense Antifungal Cream with GenRx ComplexTM (4 oz tube label)
- INGREDIENTS AND APPEARANCE
GENRX DAILY DEFENSE ANTIFUNGAL
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59088-746 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength KUKUI NUT OIL BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CETYL PHOSPHATE CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTYLENE GLYCOL PHENOXYETHANOL WATER HYALURONATE SODIUM SODIUM HYDROXIDE STEARYL ALCOHOL 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)