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

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CR-371059 Tolnaftate 1% Cream

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

CR-371059 BX Master

CR-371059 TOLNAFTATE 1% CREAM 
cr-371059 tolnaftate 1% cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1315-431 g in 1 BOX; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/01/2021
Labeler - Rugby Laboratories (079246066)

Revised: 11/2023
Document Id: 0b39a617-72d2-513e-e063-6394a90a7192
Set id: b95a76ad-9b4c-692a-e053-2995a90abd1a
Version: 4
Effective Time: 20231128
 
Rugby Laboratories