Label: FUNGISTAT MAX- clotrimazole transdermal liquid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 37945-908-12, 37945-908-13 - Packager: Bio-Medical & Pharmaceutical Manufacturing Corporation
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 5, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)
