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Antifungal by Unifirst First Aid Corporation

Medically reviewed on March 19, 2018

Dosage form: cream
Ingredients: tolnaftate 10mg in 1g
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-229

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 Facts

Active Ingredient

Tolnaftate 1.0%

Purpose

Antifungal

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • With daily use, helps prevent most athlete's foot and helps keep it from coming back.
  • For relief of itching or chaffing associated with jock itch, itchy, scaling skin between the toes, or itchy, burning feet.

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 the eyes.

Stop use and ask doctor if
  • irritation occurs
  • there is no improvement within 4 weeks (in the case of athlete's foot or ringworm) or within 2 weeks (in the case of jock itch).

Keep out of reach of children.

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

Directions
  • Supervise children in the use of this product.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • For the treatment or prevention of athlete's foot: Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm: Use daily for 4 weeks. If the condition lasts longer, consult a doctor.
  • For jock itch: Use daily for 2 weeks. If the condition lasts longer, consult a doctor.
  • To prevent athlete's foot: Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
  • This product is not effective on the scalp or nails.

Other information
  • store at 59-86°F (15-30°C)

Inactive ingredients

cetyl alcohol, chloroxylenol (PCMX), glycereth-26, mineral oil, petrolatum, purified water, sodium citrate

PRINCIPAL DISPLAY PANEL – 144 count box

MEDI-FIRST

NDC 47682-229-35

MEDI-FIRST
Antifungal Cream

144 Units
1/32 oz. (0.9 g) pouches

PRINCIPAL DISPLAY PANEL – packet

MEDI-FIRST
Antifungal Cream
1/32 oz. (0.9 g) pouches
Manufactured for
Medique Products
Fort Myers, FL 33967
800-634-7680
www.mediqueproducts.com

ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-229
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tolnaftate (tolnaftate) tolnaftate10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol 
glycereth-26 
mineral oil 
petrolatum 
water 
sodium citrate 
chloroxylenol 
Packaging
#Item CodePackage Description
1NDC:47682-229-35144 PACKET in 1 BOX
10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/30/2002
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(47682-229)

 
Unifirst First Aid Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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