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Anti-Fungal by Rugby Laboratories

Dosage form: powder
Ingredients: TOLNAFTATE .45g in 45g
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.

Active Ingredients Section

Drug Facts  Active Ingredient Tolnaftate 1 %

Purpose Section

Antifungal

Keep Out of Reach of Children Section

Keep out of reach of children

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

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 Section

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)

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

Dosage and Administration Section

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

Inactive Ingredient Section

Inactive ingredients

starch, talc

Other Information Section

Other information

store between 2 degrees and 30 degrees C (36 degrees and 86 degrees F)

Questions or comments? Section

Questions or comments? Call 1-800-645-2158, 9am - 5 pm EST, Monday -Friday

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) Rugby  COMPARE TO ACTIVE INGREDIENT IN TINACTIN

Rugby Laboratories Inc is not affiliated with the owner of the trade mark Tinactin

Rugby Anti-Fungal Powder is distributed by Rugby Laboratories Inc.

ANTI-FUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5150
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE.45 g  in 45 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 (109178264)
Registrant - Rugby Laboratories (109178264)

Revised: 11/2011
 
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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