Update-85398-006-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:36:56

Label at a glance#

ProductAthlete Foot Cream
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Terbinafine Hydrochloride 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea crurs) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

OTC - WHEN USING SECTION

do not get into eyes, if eye contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

stop use and ask a doctor if too much irritation occurs or gets worse.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, call a poison control centre or get medical help right away.

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years and over
■ use the tip of the cap to break the seal and open the tube
■ wash the affected skin with soap and water and dry completely before applying
■ for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
■ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
■ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
■ for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
■ wash hands after each use
■ children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

■ Do not use if seal on tube is broken or is not visible.
■ Store at 68–77°F (20–25°C)

INACTIVE INGREDIENT SECTION

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum

OTC - QUESTIONS SECTION

service@hermonhealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

foot creamfoot cream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-00685398-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 01:48:20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
ndc (package): 85398-006-01
ndc11 (package): 85398000601
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
ndc (package): 85398-006-01
ndc (product): 85398-006
ndc11 (package): 85398000601
spl id: 5567002c-6358-9fe7-e063-6294a90ab509
spl set id: 3b2c1d7f-32c3-aa3b-e063-6394a90a6267

Reported adverse events (FAERS/openFDA)#

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