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Anti-Fungal by Rugby Laboratories

Dosage form: powder
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Rugby Laboratories
NDC Code: 0536-5150

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.

Rugby Tolnaftate

Active Ingredients Section

Drug Facts  Active Ingredient Tolnaftate 1 %

Purpose Section

Antifungal

Uses

  • for effective treatment of most athlete's foot (linea pedis), jock itch (tinea cruris) and ring worm (tiea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • clears up most athlete's foot infection and with daily use helps to keep it from coming back

Warnings

For external use only

Do not use on children under 2 years of age.
When using this product avoid contact with the eyes
Stop use and ask a doctor if

  • irritation occurs
  • if there is no improvement within 4 weeks (for athlete's foot) or within 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

shake well before use

  • 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
  • supervise children in the use of this product
  • this product is not effective on the scalp or nails

For athlete's foot

  • use daily for 4 weeks
  • pay special attention to the spaces between the toes
  • wear well-fitting ventilated shoes
  • change shoes and socks at least once a daily
  • to prevent athlete's foot: clean and dry feet thoroughly, apply once or twice daily

For jock itch

  • use daily for 2 weeks

Other Information
  • store between 2˚-30˚C (36˚-86˚F)

Inactive Ingredient

starch, talc

Questions or comments?

1-800-645-2158

Package Label Section

Rugby

NDC 0536-5150-26

Anti-

Fungal

Powder

TOLNAFTATE 1% USP

CURES MOST ATHLETE'S FOOT AND JOCK ITCH

Net wt 1.5 oz (45 g)

Compare to active ingredient in tinactin*

ANTI-FUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5150(NDC:75841-199)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TALC 
Packaging
#Item CodePackage Description
1NDC:0536-5150-2645 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/01/2011
Labeler - Rugby Laboratories (079246066)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861relabel(0536-5150), manufacture(0536-5150)

Revised: 11/2017
 
Rugby Laboratories

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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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