1 % Tolnaftate Cream, USP

Antifungal Cream by

Drug Labeling and Warnings

Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIFUNGAL CREAM- antifungal cream 
BluePoint Laboratories

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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1 % Tolnaftate Cream, USP

Active Ingredient

Active Ingredient Purpose







Tolnaftate 1.0% Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort

Warnings For External use only

  • Do not use on children under 2 years of age unless directed by a doctor

For external use only

When using this productavoid conatct with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directy by a doctor.
  • supervise children in the use of this product.

Dosage and Administration

  • 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 the scalp or nails

Keep Out Of Reach Of Children

KEEP OUT Of REACH Of CHILDREN

if swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

Inactive Ingredients: Ceteth-20, Cetostearyl alcohol, Chlorocresol, Mineral Oil, Propylene glycol, Purified Water, Sodium Phosphate, Monobasic Dihydrate, White Petrolatum.

Contact 1-800-707-4621

  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • See crimp of tube or carton for lot number and Expiry Date

1% Tolnaftate Cream, USP Carton (1oz/28.4g)
NDC: 68001-478-45

Tolnaftate 1oz Carton

1% Tolnaftate Cream, USP Tube Label (1oz/ 28.4g)
NDC: 68001-478-45

Tolnaftate 1oz Label

1% Tolnaftate Cream, USP Carton (0.5oz/ 14.2g)
NDC: 68001-478-46

Tolnaftate 0.5oz Carton

1% Tolnaftate Cream, USP Tube Label (0.5oz/ 14.2g)
NDC: 68001-478-46

Tolnaftate 0.5oz Label

ANTIFUNGAL CREAM 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68001-478
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CHLOROCRESOL (UNII: 36W53O7109)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68001-478-451 in 1 CARTON12/03/202012/04/2020
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 68001-478-461 in 1 CARTON12/03/202012/04/2020
214.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/25/202012/04/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Gopaldas Visram & Co., Ltd858030888manufacture(68001-478)

Revised: 9/2023
 

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