Label: ANTIFUNGAL- tolnaftate solution
- NDC Code(s): 45802-033-85
- Packager: Perrigo New York Inc
- 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
- for effective treatment of most:
- athlete’s foot (tinea pedis)
- ringworm (tinea corporis)
- jock itch (tinea cruris)
- for effective relief of itchy, scaly skin between the toes
- helps prevent most athlete’s foot from coming back with daily use
For external use only.
Stop use and ask a doctor if
- irritation occurs
- athlete’s foot or ringworm does not improve within 4 weeks
- jock itch does not improve 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 thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night)
- supervise children in the use of this product
For athlete’s foot
- use daily for 4 weeks
- pay special attention to the spaces between the toes
- wear well-fitting, ventilated shoes
- change shoes and socks at least once daily
- to prevent athlete’s foot, clean and dry feet thoroughly. Apply as above once or twice daily.
- use daily for 4 weeks. If condition lasts longer, ask a doctor
For jock itch
- use daily for 2 weeks. If condition lasts longer, ask a doctor
- this product is not effective on the scalp or nails
- Inactive ingredients
butylated hydroxytoluene, polyethylene glycolClose
- Questions or comments?
- Principal Display Panel
For the cure of most athlete’s foot, jock itch & ringworm
Antifungal Solution Carton
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-033 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 mg in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-033-85 1 in 1 CARTON 1 10 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/06/2005 Labeler - Perrigo New York Inc (078846912)