FUNGUS RELIEF - tolnaftate solution 
Swabplus Inc.

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.

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Fungus Relief Swab

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

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  
tolnaftate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65734-348
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65734-348-36 36 in 1 PACKAGE
1 NDC:65734-348-00 0.15 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 03/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
Name Address ID/FEI Business Operations
Swabplus Inc. 876441549 manufacture(65734-348) , relabel(65734-348) , repack(65734-348)

Revised: 1/2015
Document Id: 5bc934c7-f185-4f4f-b866-26591873fbe9
Set id: 3c60459f-19c3-479a-b17e-ac0cbd9dc75e
Version: 6
Effective Time: 20150128
 
Swabplus Inc.