QC Anti-Fungal Cream 1oz NBE Tinactin

Manufacturer
Chain Drug Marketing Association Inc
Effective date
2017-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:53:24

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose Tolnaftate 1%....................................................................Antifungal

OTC - PURPOSE SECTION

Uses clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) helps prevent most athlete's foot recurring when used daily effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Uses

INDICATIONS & USAGE SECTION

Directions wash affected area and dry thoroughly apply a thin layer over 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, pay special attention to space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily use daily for 4 weeks; if condition persists longer, ask a doctor 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

Warnings

WARNINGS SECTION

Warnings For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Distributed By Quality Choice Novi, Mi 48376-0995 Made in Korea

Other Label Information

STORAGE AND HANDLING SECTION

Other information store between 2° and 30° C (36° and 86° F) Lot No. and Exp. Date:see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

Label Images#

QC_Tolnaftate_TB
QC_Tolnaftate_TB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN5
103951tolnaftate 10 MG/ML Topical CreamSCD5
103951tolnaftate 1 % Topical CreamSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-104-462022-01-28C16284748780-1d6a99b39-d02d-a426-e053-dadaa90af4c2QC Anti-Fungal Cream 1oz NBE Tinactin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-104-46Quality Choice Tolnaftate Antifungal1 in 1 CARTONCREAM15
63868-104-46Quality Choice Tolnaftate Antifungal30 g in 1 TUBECREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-104QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]5Legacy NDC, 2 package rows20171213_684e9447-e16e-42e2-b268-e37b48eb2e92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-104-46GM - Gram63868-104364f5a3c-656d-44ea-ad4e-a31ae850437412013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV4
TOLNAFTATEACTIVE MOIETY06KB629TKV4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-10463868-104-46

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose Tolnaftate 1%....................................................................Antifungal

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Uses clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) helps prevent most athlete's foot recurring when used daily effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

WARNINGS SECTION

WARNINGS SECTION

Warnings For external use only

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Directions wash affected area and dry thoroughly apply a thin layer over 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, pay special attention to space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily use daily for 4 weeks; if condition persists longer, ask a doctor 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

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

Other information store between 2° and 30° C (36° and 86° F) Lot No. and Exp. Date:see box or see crimp of tube

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Distributed By Quality Choice Novi, Mi 48376-0995 Made in Korea

Source Document#

Source XML