Your browser does not support JavaScript! FUNGUS RELIEF SWABS (TOLNAFTATE) LIQUID [SWABPLUS INC.]
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FUNGUS RELIEF SWABS (tolnaftate) liquid
[Swabplus Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Cures fungal infections of the toes and fingers, including skin around and under nails, where accessible with swab applicator. Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) and relieves symptoms of athlete's foot including itching, burning and scaly skin.
  • Help prevent most athlete's foot from recuring when uses daily.

Warings


For external use only.
When using this product avoid contact with eyes.
Stop use and ask a doctor if irritation occurs. 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 the reach of children

If swallowed get  medical help or contact a Poison Control Center right away.

Directions

  • Do not use if label seal is broken prior to purchase.
  • Keep swabs in original container when not in use.
  • wash affected area and dry thoroughly.
  • Hold the swab vertically with the color band tip upwards.
  • Bend the tip at the color band to one side until it snaps.
  • Apply a thin layer over affected area twice daily (morning and night)
  • Discard swab after use.
  • For athlete's foot, apply once or twice daily, pay special attention to spaces between toes, wear shoes with good ventilation and change shoes and socks at least once daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

Other information


Avoid storing at excessive heat.

Inactive Ingredients

Aloe Barbadensis Leaf Extract. BHT. Butylene Glycol, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Propylene Glycol, Propylparaben. Tocopheryl Acetate

Image of carton label

Image of fungus carton label

FUNGUS RELIEF SWABS  
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65734-348
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BUTYLATED HYDROXYTOLUENE 
BUTYLENE GLYCOL 
DIAZOLIDINYL UREA 
DIETHYLENE GLYCOL MONOETHYL ETHER 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-348-365 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc.876441549manufacture(65734-348), relabel(65734-348), repack(65734-348)

Revised: 2/2013
 
Swabplus Inc.

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