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NDC 75983-0002-02 First Aid Antifungal Medicated 10 mg/g Details

First Aid Antifungal Medicated 10 mg/g

First Aid Antifungal Medicated is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by First Aid Research Corp.. 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: 75983-0002-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tolnaftate

Product Information

NDC	75983-0002
Product ID	75983-002_d8c3138a-cad7-fb0f-e053-2a95a90a4a53
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	First Aid Antifungal Medicated
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	First Aid Research Corp.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2023-12-31

Package

Package Images

NDC 75983-0002-02 (75983000202)

Pricing Information	N/A
NDC Package Code	75983-002-02
Billing NDC	75983000202
Package	1 TUBE in 1 CARTON (75983-002-02) / 28 g in 1 TUBE (75983-002-01)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7ae2f6f-bae3-573a-e053-2a95a90a7fa0 Details

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 with daily use
for effective relief of itching, burning and cracking

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 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 shoes and change 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 scalps or nails

Other information

store between 20 to 25°C (68 to 77°F)
Lot No & Expiration Date: See box or see crimp

Inactive ingredients

petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene, propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.

SPL UNCLASSIFIED SECTION

Distributed by:

First Aid Research Corp.

Jupiter, Florida, USA 33478

Made in India

PRINCIPAL DISPLAY PANEL

First Aid Antifungal Medicated Cream

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

FIRST AID ANTIFUNGAL MEDICATED

tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75983-002
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
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	white (White to Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75983-002-02	1 in 1 CARTON	01/01/2020
1	NDC:75983-002-01	28 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	01/02/2018

Labeler - First Aid Research Corp. (089405927)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(75983-002)

Revised: 2/2022

Document Id: d8c3138a-cad7-fb0f-e053-2a95a90a4a53

Set id: b7ae2f6f-bae3-573a-e053-2a95a90a7fa0

Version: 3

Effective Time: 20220224