Scholls Wellness Company LLC

Manufacturer
Scapa Tapes North America, LLC
Effective date
2023-08-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:27:25

Label at a glance#

ProductScholls Wellness Company LLC Ingrown Toenail
Active ingredientSODIUM SULFIDE
Label structure14 sections

Dosage and administration

adults and children 12 years and over: wash affected area and dry thoroughly place retainer ring on toe with slot over the area where the ingrown nail and the skin meet. Smooth ring down firmly. cut open tip of tube on score mark. Apply enough gel product to fill the slot in the ring. Immediately replace cap on tube. place round center section of bandage directly over the gel-filled ring to seal the gel in place. ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Sodium sulfide 1%........................Ingrown toenail reliever

Purpose

OTC - PURPOSE SECTION

Ingrown toenail reliever

Use

INDICATIONS & USAGE SECTION

for temporary relief of pain and discomfort from ingrown toenails

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on open sores

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have

  • diabetes
  • poor blood circulation
  • gout

When using this product

OTC - WHEN USING SECTION

  • use with a retainer ring
  • avoid contact with eyes. If product gets in eyes, flush with water for 15 minutes and get medical help right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • redness or swelling of your toe increases
  • discharge is present around the nail
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:

wash affected area and dry thoroughly

place retainer ring on toe with slot over the area where the ingrown nail and the skin meet. Smooth ring down firmly.

cut open tip of tube on score mark. Apply enough gel product to fill the slot in the ring. Immediately replace cap on tube.

place round center section of bandage directly over the gel-filled ring to seal the gel in place. Smooth ends of bandage strip around toe.

repeat twice daily (morning and night) for up to 7 days until pain and discomfort is relieved or until the nail can be lifted out of the nail groove and easily trimmed.

children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • save carton for full labeling
  • keep tube tightly closed when not in use
  • store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

edetate disodium, hydroxyethyl cellulose, potassium acetate, water

Questions

OTC - QUESTIONS SECTION

Questions? 1-866-360-3226

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ingrown ToenailIngrown Toenail

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66843-721-412024-01-30C16284748780-11030e365-16ce-111a-e063-dadaa90a10e2Ingrown Toenail (Scapa)

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
66843-72166843-721-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
02acffc0-6a55-3109-e063-6394a90a27eed672a50e-e915-4355-e053-2a95a90a52482023-08-11WarningsExact identifier
spl id: 02acffc0-6a55-3109-e063-6394a90a27ee
spl set id: d672a50e-e915-4355-e053-2a95a90a5248

Reported adverse events (FAERS/openFDA)#

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