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

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

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

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

ANTIFUNGAL CREAM 
antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-478
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-478-45	1 in 1 CARTON	12/03/2020	12/04/2020
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68001-478-46	1 in 1 CARTON	12/03/2020	12/04/2020
2		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/25/2020	12/04/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-478)

Revised: 9/2023

Document Id: 0439da7e-deb7-9cbc-e063-6294a90a1c76

34390-5

Set id: b5904d39-ba21-525b-e053-2a95a90a61f3

Version: 3

Effective Time: 20230904