Tolnaftate Cream

Tolnaftate Cream

Drug Labeling and Warnings

Drug Details

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TOLNAFTATE- tolnaftate cream 
Galentic Pharma (India) Private Limited

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.

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Tolnaftate Cream

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

USES

  • Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Proven effective in the prevention of athlete's foot.
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet.

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 immediately.

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
  • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. If condition persists longer consult a doctor
  • This product is not effective on scalp or nails

OTHER INFORMATION

  • Store at 15° to 30°C (59° to 86°F)
  • Lot No. & Exp. Date. See box or crimp of tube.

INACTIVE INGREDIENT

Cetyl alcohol, Liquid paraffin, Methylparaben, Polyoxyethylene Cetylether, Propylene Glycol, Propylparaben, Stearyl Alcohol, Sorbitan Monostearate, Purified water.

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

Galentic

Tolnaftate
Cream USP, 1%

ANTIFUNGAL

Medicated Cream
Relieves itching and burning
Cures most Athlete's Foot

NET WT.
0.5 OZ. (14g)

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-014
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
Cetyl Alcohol (UNII: 936JST6JCN)  
CETETH-20 (UNII: I835H2IHHX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitan Monostearate (UNII: NVZ4I0H58X)  
Water (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-014-121 in 1 CARTON06/01/2012
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C06/01/2012
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-014) , MANUFACTURE(50382-014) , PACK(50382-014) , REPACK(50382-014) , STERILIZE(50382-014)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-014) , MANUFACTURE(50382-014) , PACK(50382-014) , REPACK(50382-014) , STERILIZE(50382-014)

Revised: 12/2017
 
Galentic Pharma (India) Private Limited


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