ANTI-FUNGAL- tolnaftate powder

Anti-Fungal by

Drug Labeling and Warnings

Anti-Fungal by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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*

INGREDIENTS AND APPEARANCE

ANTI-FUNGAL 
tolnaftate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-5150(NDC: 75841-199)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-5150-26	45 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/01/2011

Labeler - Rugby Laboratories (079246066)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	relabel(0536-5150) , manufacture(0536-5150)