FDA.reportPublic FDA data

Up and Up Soothing Antifungal

Manufacturer
Formulated Solutions, LLC
Effective date
2023-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:24

Label at a glance#

ProductUp and Up Soothing Antifungal
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most athlet's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief if itching, burning, cracking

Dosage and administration

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 for athlete's foot: pay special attention to spaces between the toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily use daily for 4 weeks; if condition persist longer, ask a doctor to prevent athlete's foot,...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlet's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief if itching, burning, cracking

Warnings

WARNINGS SECTION

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not punture or incinerate. Do not store at temperature above 120°F (49°C).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • for athlete's foot: pay special attention to spaces between the toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
  • use daily for 4 weeks; if condition persist 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

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol denat, butylated hydroxytoluene, isobutane, polyethylene glycol 300, polysorbate 20

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Up and Up 816Up and Up 816

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN2
313423tolnaftate 10 MG/ML Topical SolutionSCD2
313423tolnaftate 1 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23667-816-01Up and Up Soothing Antifungal150 g in 1 CANLIQUID1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23667-816UP AND UP SOOTHING ANTIFUNGAL (TOLNAFTATE) LIQUID [FORMULATED SOLUTIONS, LLC]2Legacy NDC, 1 package rows20231207_46c63c9a-d471-382e-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23667-81623667-816-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYSORBATE 207T1F30V5YHIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
567fff06-902e-1ca1-e063-6394a90a312746c63c9a-d471-382e-e054-00144ff8d46c2026-07-13WarningsExact identifier
spl set id: 46c63c9a-d471-382e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.