EQUALINE TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
SUPERVALU INC

Disclaimer: 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.

----------

Equaline Antifungal Cream 0.5 and 1 oz NBE Tinactin

Active Ingredient                                                                              Purpose

Tolnaftate 1% .............................................................................. Antifungal

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking

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 4 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) or as directed by a doctor
  • 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)
  • This product is not effective on the scalp or nails

Other Information

  • Store between 20 o to 25 oC (68 o to 77 oF)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive ingredients

butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearly alcohol

DISTRIBUTED BY

SUPERVALU INC.

EDEN PRAIRIE,

MN 55344 USA

MADE IN KOREA



image description

image description

EQUALINE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETETH-20 (UNII: I835H2IHHX)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-251-461 in 1 CARTON09/28/2011
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:41163-251-471 in 1 CARTON09/28/2011
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/28/201105/19/2020
Labeler - SUPERVALU INC (006961411)

Revised: 12/2021
 
SUPERVALU INC