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NDC 49035-0499-03 equate 10 mg/g Details

equate 10 mg/g

equate is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. 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: 49035-0499-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tolnaftate

Product Information

NDC	49035-0499
Product ID	49035-499_a25ac6a8-c431-41f2-bc7e-aa5f14b3bf9e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	equate
Proprietary Name Suffix	Athletes Foot
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	Wal-Mart Stores Inc
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 49035-0499-03 (49035049903)

Pricing Information	N/A
NDC Package Code	49035-499-03
Billing NDC	49035049903
Package	1 TUBE in 1 CARTON (49035-499-03) / 30 g in 1 TUBE
Marketing Start Date	2006-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e90297d0-0f87-4ae3-b9b7-959266d57c24 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate1%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
helps prevent most 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 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)
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° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

BHT, PEG-400, PEG-3350, Titanium Dioxide, White Petrolatum

Questions?

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC 49035-499-03

equate™

Compare to

Tinactin®

Active

Ingredient*

Athlete's

Foot

TOLNAFTATE CREAM 1%

ANTIFUNGAL

Cures and prevents

most athlete's foot

Relieves burning & itching

NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Tube Carton

INGREDIENTS AND APPEARANCE

EQUATE ATHLETES FOOT

tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-499
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
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Polyethylene glycol 400 (UNII: B697894SGQ)
titanium dioxide (UNII: 15FIX9V2JP)
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-499-03	1 in 1 CARTON	02/17/2006
1		30 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	02/17/2006

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(49035-499)

Revised: 2/2019

Document Id: a25ac6a8-c431-41f2-bc7e-aa5f14b3bf9e

Set id: e90297d0-0f87-4ae3-b9b7-959266d57c24

Version: 3

Effective Time: 20190206

Search by Drug Name or NDC

NDC 49035-0499-03 equate 10 mg/g Details

equate 10 mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49035-0499-03 (49035049903)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e90297d0-0f87-4ae3-b9b7-959266d57c24 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

INGREDIENTS AND APPEARANCE

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