![FUNGISTAT MAX (CLOTRIMAZOLE TRANSDERMAL LIQUID) LIQUID [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]](https://medic.hrt.org//dailymed/images/2fc20e9c-c95a-6a41-e054-00144ff8d46c/Kleer-Plex 1 oz Fungistat Pro Toe & Foot Fungus Cure 3 x 1.5 Label 160401 RGB.jpg)
| NDC | 37945-908-12, 37945-908-13 |
| Set ID | 2fc20e9c-c95a-6a41-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Bio-Medical & Pharmaceutical Manufacturing Corporation |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | PART333C |
- Drug Facts
- Active Ingredient
- Purpose
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Indications
- Cures most tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).
- Relieves itching, burning feet and itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch.
- Clears up most athlete’s foot infection and with daily use helps keep it from coming back.
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Warnings
- Do not use on children under 2 years of age unless directed by a doctor.
- For external use only.
- Avoid contact with the eyes.
- For Athlete’s Foot: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
- For Jock Itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
- Do not use for diaper rash.
- Flammable – Do not use near open flame or heat source.
- Keep Out Of Reach Of Children
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Directions
- Wash 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.
- The brush applicator allows easy application under the nails and surrounding cuticle area.
- Always use well-ventilated shoes and change socks at least once each day.
- Supervise children in the use of this product.
- For Athlete’s Foot: Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and changes shoes and socks at least once daily.
- For Athlete’s Foot & Ringworm: Use daily for 4 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Inactive Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FUNGISTAT MAX
clotrimazole transdermal liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-908 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ARNICA MONTANA (UNII: O80TY208ZW) UNDECYLENIC ACID (UNII: K3D86KJ24N) PEPPERMINT OIL (UNII: AV092KU4JH) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM PROPIONATE (UNII: DK6Y9P42IN) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBIC ACID (UNII: X045WJ989B) PROPIONIC ACID (UNII: JHU490RVYR) THYMOL (UNII: 3J50XA376E) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYL ETHYL KETONE (UNII: 6PT9KLV9IO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-908-12 1 in 1 BOX 04/12/2016 1 NDC:37945-908-13 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/12/2016 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-908)
