CR-371059 TOLNAFTATE 1% CREAM cream

CR-371059 Tolnaftate 1% Cream by

Drug Labeling and Warnings

CR-371059 Tolnaftate 1% Cream by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Helps prevent most athlete's foot with daily use

For effective relief of itching, burning, and cracking

Warnings

For External Use Only

This product is not effective on the scalp or nails

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

Irritation occurs

There is no improvement within 4 weeks

Keep out of reach of children

If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Directions

Wash affected area and dry thoroughly

Apply a thin layer over affected area twice daily (morning and night)

Supervise children in the use of this product

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks

at least once daily

Use daily for 4 weeks; if condition persists longer, ask a doctor

To prevent athlete's foot, apply once or twice daily (morning and/or night)

Other Information

Store between 20° to 25ºC (68º to 77ºF)

Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

Questions and Comments?

1-800-645-2158

Label

INGREDIENTS AND APPEARANCE

CR-371059 TOLNAFTATE 1% CREAM 
cr-371059 tolnaftate 1% cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1315
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
CETETH-20 (UNII: I835H2IHHX)
MINERAL OIL (UNII: T5L8T28FGP)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1315-43	1 g in 1 BOX; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/01/2021

Labeler - Rugby Laboratories (079246066)