Label: SCHOLLS WELLNESS COMPANY LLC INGROWN TOENAIL- sodium sulfide gel

  • NDC Code(s): 73469-7214-1
  • Packager: Scholls Wellness Company LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 14, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    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

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on open sores
  • ASK DOCTOR/PHARMACIST

    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

    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

    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 INGREDIENT

    Inactive ingredients

    edetate disodium, hydroxyethyl cellulose, potassium acetate, water

  • Questions

    Questions? 1-866-360-3226

  • PRINCIPAL DISPLAY PANEL

    Ingrown Toenail

  • INGREDIENTS AND APPEARANCE
    SCHOLLS WELLNESS COMPANY LLC  INGROWN TOENAIL
    sodium sulfide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73469-7214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM SULFIDE (UNII: YGR27ZW0Y7) (SULFIDE ION - UNII:G15I91XETI) SODIUM SULFIDE1 g  in 10 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:73469-7214-11 in 1 CARTON01/01/202108/31/2023
    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 - Scholls Wellness Company LLC (117174744)
    Registrant - Scapa Tapes North America, LLC (079995435)