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NDC 00904-0722-36 Tolnaftate 10 mg/g Details

Tolnaftate 10 mg/g

Tolnaftate is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is TOLNAFTATE.

MedlinePlus Drug Summary

Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00904-0722-36
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tolnaftate

Product Information

NDC	00904-0722
Product ID	0904-0722_d4c0d927-7a7a-4b89-ba8e-5f05659586bf
Associated GPIs	90150085003705
GCN Sequence Number	007339
GCN Sequence Number Description	tolnaftate CREAM (G) 1 % TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	30300
HICL Sequence Number	003186
HICL Sequence Number Description	TOLNAFTATE
Brand/Generic	Generic
Proprietary Name	Tolnaftate
Proprietary Name Suffix	n/a
Non-Proprietary Name	TOLNAFTATE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	TOLNAFTATE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-0722-36 (00904072236)

Pricing Information
NDC Package Code	0904-0722-36
Billing NDC	00904072236
Package	1 TUBE in 1 CARTON (0904-0722-36) / 14.18 g in 1 TUBE
Marketing Start Date	2010-02-11
NDC Exclude Flag	N
Price Per Unit	0.09509
Pricing Unit	GM
Effective Date	2022-05-18
NDC Description	ANTIFUNGAL 1% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 5a05dc53-f817-40bd-9355-a3266afb1179 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate USP 1%

Purpose

Antifungal

Uses

for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
for effective relief of itchy, scaly skin between the toes
clears up most athlete's foot infection and with daily use helps keep it from coming back

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product avoid contact with eyes

Stop use and ask a doctor if

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

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

clean the affected area and dry thoroughly
apply a thin layer of the product over the 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

use daily for 4 weeks. If condition persists longer, consult a doctor
pay special attention to the spaces between the toes
wear well fitting ventilated shoes
change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

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.

Other information

Store at controlled room temperature 15°-30°C (59°-86°F)
Lot No. and Exp date: see crimp on tube or see box

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic, White Petrolatum

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Principal Display Panel – 0.5 oz Tube

MAJOR® *Compare to Active Ingredient of Tinactin®

NDC 0904-0722-36

Antifungal

Cream (Tolnaftate 1%) N309040722362

CURES ATHLETE'S FOOT, *This product is not manufactured or

JOCK ITCH AND RINGWORM distributed by Schering-Plough Healthcare

Relives Burning and Itching Products, Inc. owner of the registered

• Odorless • Greaseless • Non-Staining trademark, Tinactin®

Net Wt. 0.5 OZ (14.18 g)

Principal Display Panel – 0.5 oz Carton

MAJOR® NDC 0904-0722-36

Antifungal *Compare to Active Ingredient of Tinactin®

Cream

(Tolnaftate 1%) Net Wt. 0.5 OZ (14.18 g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE

tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-0722
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-0722-36	1 in 1 CARTON	02/11/2010
1		14.18 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/11/2010

Labeler - Major Pharmaceuticals (191427277)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0904-0722)

Revised: 12/2021

Document Id: d4c0d927-7a7a-4b89-ba8e-5f05659586bf

Set id: 5a05dc53-f817-40bd-9355-a3266afb1179

Version: 3

Effective Time: 20211201