TOLNAFTATE ANTIFUNGAL- tolnaftate powder

TOLNAFTATE ANTIFUNGAL by

Drug Labeling and Warnings

TOLNAFTATE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use on children under 2 years of age.

Do not use for diaper rash.

For external use only

When using this product avoid contact with the eyes

Stop use and consult a doctor if

• irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
• irritation occurs or if there is no improvement 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

For athlete's foot

• use daily for 4 weeks. If condition persists longer, consult a doctor
• 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 as above or twice daily

For ringworm

• use only for 4 weeks. If condition persists longer, consult a doctor.

For jock itch

• use daily for 2 weeks. If condition persists longer, consuly a doctor.

This product is not effective on the scalp or nails.

Other Information

• store at room temperature

Inactive Ingredients

starch and talc

Questions or comments?

Call: 800-616-2471

Package Label

NDC: 0904-0726-45

TOLNAFTATE ANTIFUNGAL POWDER 1%

Cures Athlete's Foot Jock Itch Fungi and Ringworm

Compare to the active ingredient on Tinactin*

MAJOR

net Wt. 45g (1 1/2 oz.)

INGREDIENTS AND APPEARANCE

TOLNAFTATE ANTIFUNGAL 
tolnaftate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-0726(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: 0904-0726-45	45 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/01/2017

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

Labeler - Major Pharmaceuticals (191427277)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(0904-0726) , relabel(0904-0726)