SCHOLLS WELLNESS COMPANY LLC INGROWN TOENAIL- sodium sulfide gel

Scholls Wellness Company LLC by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SCHOLLS WELLNESS COMPANY LLC  INGROWN TOENAIL
sodium sulfide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73469-7214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM SULFIDE (UNII: YGR27ZW0Y7) (SULFIDE ION - UNII:G15I91XETI)	SODIUM SULFIDE	1 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM ACETATE (UNII: M911911U02)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73469-7214-1	1 in 1 CARTON	01/01/2021	08/31/2023
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358D	01/01/2021

Labeler - Scholls Wellness Company LLC (117174744)

Registrant - Scapa Tapes North America, LLC (079995435)