Label: TINEACIDE ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 63347-502-01
- Packager: Blaine Labs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated May 7, 2013
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- Active Ingredient
Miconazole Nitrate 2%Close
- Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
- Cures most athlete's foot (tinea pedis).
- Cures most jock inch (tinea cruris) and ring worm (tinea corporis).
- Relieves itching, burning, cracking, and scaling which accompany these conditions.
- For external use only.
- Do not use in or near the mouth or eyes.
- Do not use for vaginal yeast infections.
- When using this product,
do not get into the eyes. If eye contact occurs, rinse thoroughly with water.Close
- Stop use and consult a physician if
irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).Close
- Adult and children 2 years and older. Children under 2 years: ask physician.
- Wash the affected area with soap and water and dry thoroughly before applying.
- For athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 4 weeks (morning and night), or as directed by a physician.Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- For jock itch and ringworm apply twice daily to affected skin for 2 weeks or as directed by a physician. This product is not effective on the scalp or mails.
- Wash hands after each use.
- Other Information
- Do not use if seal on bottle is broken or is not visible.
- Store between 2° and 30° C (36° and 85° F)
- Inactive Ingredients
Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, lavandula Angustifolia Lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.Close
- Product Label
Kills the skin fungus that causes fungal nails
Treats mild to severe infections
NET WT 1.25 OZ (35 g)
5 FUNGUS FIGHTERS
NEW and IMPROVED FORMULATION 100% MONEY-BACK GUARANTEE!
BONUS: Easy-Grip, Heavy-Duty Nail Clipper!
Proudly made in the U.S.A.!
Please Recycle! This package is made from recyclable materials.
Questions or Comments? Call (800) 307-8818 Monday-Friday 8:00AM and 5:00PM (EST)
Blaine Labs Inc. Santa Fe Springs, CA 90670 www.DrBlaines.com All rights reserved.
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-502 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 0.7 g in 35 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) CLOTRIMAZOLE (UNII: G07GZ97H65) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) LAVENDER OIL (UNII: ZBP1YXW0H8) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) TROLAMINE (UNII: 9O3K93S3TK) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63347-502-01 35 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/01/2013 Labeler - Blaine Labs Inc. (017314571) Registrant - Blaine Labs Inc. (017314571) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture(63347-502)