Label: FUNGISTAT MAX- clotrimazole liquid
Contains inactivated NDC Code(s)
NDC Code(s): 37945-910-44, 37945-910-45
- Packager: Bio-Medical & Pharmaceutical Manufacturing Corporation
- 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 April 8, 2016
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- Drug Facts
- Active Ingredient
- 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.
- 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
- Wash the affected area and dry thoroughly.
- Spray a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- Allow product to dry before covering.
- 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.
- For Jock Itch: Use daily for 2 weeks.
- For Jock Itch: Some discomfort upon application is normal and should fade as product dries. Do not cover until dry.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Inactive Ingredients
- Questions & Comments
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-910 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) PEPPERMINT OIL (UNII: AV092KU4JH) SODIUM PROPIONATE (UNII: DK6Y9P42IN) SORBIC ACID (UNII: X045WJ989B) PROPIONIC ACID (UNII: JHU490RVYR) WATER (UNII: 059QF0KO0R) ARNICA MONTANA (UNII: O80TY208ZW) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SALICYLIC ACID (UNII: O414PZ4LPZ) THYMOL (UNII: 3J50XA376E) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYL ETHYL KETONE (UNII: 6PT9KLV9IO) UNDECYLENIC ACID (UNII: K3D86KJ24N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-910-45 1 in 1 BOX 04/14/2016 1 NDC:37945-910-44 118 mL in 1 BOTTLE, SPRAY; 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 04/14/2016 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-910)