Scholls Wellness Company LLC by Scapa Tapes North America, LLC Ingrown Toenail (Scapa)

Scholls Wellness Company LLC by

Drug Labeling and Warnings

Scholls Wellness Company LLC by is a Otc medication manufactured, distributed, or labeled by Scapa Tapes North America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SCHOLLS WELLNESS COMPANY LLC INGROWN TOENAIL- sodium sulfide gel 
Scapa Tapes North America, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ingrown Toenail (Scapa)

Drug Facts

Active Ingredient Purpose

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

Purpose

Ingrown toenail reliever

Use

for temporary relief of pain and discomfort from ingrown toenails

Warnings

For external use only

Do not use

  • on open sores

Ask a doctor before use if you have

  • diabetes
  • poor blood circulation
  • gout

When using this product

  • 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.

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

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

Directions

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

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

Inactive ingredients

edetate disodium, hydroxyethyl cellulose, potassium acetate, water

Questions

Questions? 1-866-360-3226

Ingrown Toenail

SCHOLLS WELLNESS COMPANY LLC  INGROWN TOENAIL
sodium sulfide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66843-731
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM SULFIDE (UNII: YGR27ZW0Y7) (SULFIDE ION - UNII:G15I91XETI) SODIUM SULFIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POTASSIUM ACETATE (UNII: M911911U02)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66843-731-411 in 1 CARTON01/01/2021
11 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358D01/01/2021
Labeler - Scapa Tapes North America, LLC (079995435)
Registrant - Scapa Tapes North America, LLC (079995435)

Revised: 8/2023
Document Id: 02aca86c-2b89-bf20-e063-6394a90a71d0
Set id: 02ac9b16-bd4f-109e-e063-6294a90aa001
Version: 1
Effective Time: 20230811