TOLNAFTATE- tolnaftate jock itch powder spray talc free aerosol, spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• cures most jock itch (tinea cruis)
• relieves itching, burning and crafing associated with jock itch

WARNINGS

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

When using this product

• do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
• use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop use and ask a doctor if

• irritation occurs
• no improvement within 2 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• use daily for 2 weeks; if conditions persist, consult a doctor
• if nozzle clogs, clean with a pin

Other information

store between 20º and 30ºC (68ºF and 86ºF)

Inactive ingredients

BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

call 1-866-964-0939

Principal Display Panel

TopCare health

MEDICATED

Jock Itch

Powder Spray

TOLNAFTATE 1% ANTIFUNGAL

• Cures Most Jock Itch
• Relieves Itching, Chafing and Burning
• Talc- Free

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate jock itch powder spray talc free aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-877
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.3 g  in 130 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOBUTANE (UNII: BXR49TP611)
KAOLIN (UNII: 24H4NWX5CO)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
ALCOHOL (UNII: 3K9958V90M)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-877-46	130 g in 1 CAN; Type 0: Not a Combination Product	10/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/31/2017

Labeler - Topco Associates LLC (006935977)