Label: FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ- tolnaftate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75983-515-14 - Packager: First Aid Reserach Corp
- 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.
Drug Label Information
Updated October 9, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings
For external use only
When using this product avoid contact with the eyes
Stop use and ask a doctor if
- irritation becomes severe
- there is no improvement within 4 weeks
Do not use on children under 2 years of age except under the advice and supervision of a doctor
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- wash affected area and dry throughly
- apply a thin layer over affected area twie daily (morning and night)
- supervise children in the use of this product
- for athlete's foot:pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- use daily for 4 weeks; if condition persists longer, ask a doctor
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75983-515 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) PARAFFIN (UNII: I9O0E3H2ZE) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75983-515-14 1 in 1 CARTON 1 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/09/2014 Labeler - First Aid Reserach Corp (089405927)