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Kerasal foot and toe

Dosage form: cream
Ingredients: Clotrimazole 1g in 100g
Labeler: MOBERG PHARMA NORTH AMERICA LLC
NDC Code: 16864-182

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.

Kerasal® toe & foot™

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses
  • cures most athlete’s foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

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

When using this product

avoid contact with eyes.

Keep out of reach of children.

If accidentally swallowed, contact a doctor or poison control center immediately.

Stop use and ask a doctor
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 2 weeks (for jock itch).

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • 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/socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information
  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

www.kerasal.com

Questions? Call 877-674-3475

Principal Display Label

Kerasal® toe & foot™

Proven Effective

Toe & Foot

Antifungal

Clotrimazole Cream USP, 1% - Antifungal

Cures Most Athlete’s Foot

Relieves itching, burning & scaling

www.kerasal.com

Questions? Call 877-674-3475

NET WT 1 oz (28 g)

NDC16864-182-01

®©™, Distributed By
Moberg Pharma North America LLC,
Cedar Knolls, NJ

All Rights Reserved.

Made in Canada. Packaged in the USA.

82-3701-01

KERASAL FOOT AND TOE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-182
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol 
Cetostearyl Alcohol 
Cetyl Esters Wax 
Octyldodecanol 
Polysorbate 60 
Water 
Sorbitan Monostearate 
Packaging
#Item CodePackage Description
1NDC:16864-182-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201505/31/2018
Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals206263295MANUFACTURE(16864-182)

Revised: 01/2018
 
MOBERG PHARMA NORTH AMERICA LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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