KERASAL ATHLETES FOOT POWDER- tolnaftate spray 
Advantice Health, LLC

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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Kerasal® Athlete's Foot Powder Spray

Drug Facts

Active ingredient

(To Deliver) Tolnaftate 1%

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

Extremely Flammable do not use while smoking or near heat or flame.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes

  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

Stop use and ask doctor if

  • Irritation occurs
  • There is no improvement within 4 weeks.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • Wash the affected area and dry thoroughly
  • Shake can well and spray a thin layer over affected area twice daily (morning and night)
  • Supervise children in the use of this product
  • 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, or as directed by a doctor)
  • This product is not effective on the scalp or nails.

Other information

Store between 20-25°C (68-77°F)

Inactive ingredients

alcohol, aloe vera leaf, alpha-tocopherol acetate, butylated hydroxytoluene, ceramide NG, dimethicone, eucalyptus oil, isobutane, isododecane, methylal, peppermint oil, tapioca starch, tea tree oil

Questions?

1-877-674-3475
www.Kerasal.com

PRINCIPAL DISPLAY PANEL - 56 g Can Label

Tolnaftate Antifungal
Kerasal®

NEW

For Athlete's Foot

Invisible Powder Spray

5 IN 1™

CURES
Most Athlete's Foot

PREVENTS
Recurrence

RELIEVES
Itching, Burning And Scaling

NOURISHES
Improves Skin Appearance

DEODORIZES
With Essential Oils

Enriched with Natural Tea Tree Oil,
Aloe, Ceramides & Vitamin E

NET WT 2.0 oz (56 g)

PRINCIPAL DISPLAY PANEL - 56 g Can Label
KERASAL ATHLETES FOOT POWDER 
tolnaftate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NG (UNII: C04977SRJ5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ISOBUTANE (UNII: BXR49TP611)  
ISODODECANE (UNII: A8289P68Y2)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16864-110-0157 g in 1 CAN; Type 0: Not a Combination Product02/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C02/28/2022
Labeler - Advantice Health, LLC (192527062)

Revised: 5/2022
Document Id: 9eae4eb3-2ceb-4940-aa0e-e77222886d1b
Set id: 470d8424-21b8-48e5-8f33-e8baf65c2fb0
Version: 1
Effective Time: 20220525
 
Advantice Health, LLC