Your browser does not support JavaScript! TINACTIN (TOLNAFTATE) CREAM [MSD CONSUMER CARE, INC.]
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RxNorm Names

TINACTIN (tolnaftate) cream
[MSD Consumer Care, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • for effective relief of itching, chafing and burning

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
  • use daily for 2 weeks; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

1-866-360-3266

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary
of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 15g Tube Carton

Tinactin®
tolnaftate
ANTIFUNGAL

CREAM

Relieves:

  • itching
  • burning
  • chafing

NET WT
15g (1/2 oz)

PRINCIPAL DISPLAY PANEL - 15g Tube Carton
TINACTIN 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-0934
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ceteth-20 
cetostearyl alcohol 
chlorocresol 
mineral oil 
propylene glycol 
water 
sodium phosphate, monobasic 
petrolatum 
Product Characteristics
ColorWHITE (White to Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0934-21 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C09/23/1993
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 5/2012
 
MSD Consumer Care, Inc.

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