MedPath

Tolnafate

Best Choice Tolnaftate Jock Itch Powder Spray Talc-Free

Approved
Approval ID

1d258684-9034-460c-953d-78e2b5198167

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

VALU MERCHANDISERS, CO.

DUNS: 868703513

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolnaftate Jock Itch Powder Spray - Talc Free

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63941-540
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate Jock Itch Powder Spray - Talc Free
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (7)

BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
PPG-12-BUTETH-16Inactive
Code: 58CG7042J1
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ZEA MAYS SUBSP. MAYS WHOLEInactive
Code: 1G5HNE09V8
Classification: IACT
TOLNAFTATEActive
Quantity: 1.3 g in 130 g
Code: 06KB629TKV
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/3/2017

Principal Display Panel

Best Choice

MEDICATED

Jock Itch Powder Spray

Tolnaftate 1%

  • Cures most jock itch
  • Relieves itching, chafing and burning
  • Talc-free

NET WT 4.6 OZ (130 g)

Best Choice_Antifungal Tolnaftate Jock Itch Powder Spray_50-061BC-01.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/3/2017

Uses

  • cures most jock itch (tinea cruis)
  • relieves itching, burning and crafing associated with jock itch

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/3/2017

Active ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/3/2017

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 10/3/2017

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

When using this product

  • do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
  • use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 2 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/3/2017

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks; if conditions persist, consult a doctor
  • if nozzle clogs, clean with a pin

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 10/3/2017

Other information

store between 20º and 30ºC (68ºF and 86ºF)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/3/2017

Inactive ingredients

BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/3/2017

Questions?

call 1-866-964-0939

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