SOMXL- salicylic acid solution

SOMXL by

Drug Labeling and Warnings

SOMXL by is a Otc medication manufactured, distributed, or labeled by WR Group Skin Care Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic acid 17% (w/w)

Purpose

Wart remover

Use

For the removal of common warts. The common wart is easily recognized by the rough

"cauliflower-like" appearace on the surface.

Warnings

For external use only

If product gets into eyes, flush with water for 15-minutes. Avoid inhaling vapors.

Do not use

• on irritated skin
• on any area that is infected or reddened
• if you are diabetic or if you have poor blood circulation
• piles
• birthmarks
• warts with hair growing from them
• on moles
• warts on the face or mucous membreanes

Stop use and ask a doctor if

discomfort persists

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wash affected area (May soak wart in warm water for 15-minutes if desired).
• Dry area throughly.
• Apply small amount with applicator to cover each wart. Let dry.
• Repeat this procedure once ot twice daily as needed for up to 12-weeks.

Inactive ingredients

castor oil, ethyl lactate, flexible collodion, polybutene, (Contains alcohol 18% v/v and ether 53% v/v from flexible collodion.)

Package Labeling:

INGREDIENTS AND APPEARANCE

SOMXL 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70463-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	170 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
ETHYL LACTATE (UNII: F3P750VW8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70463-000-01	1 in 1 BOX	08/01/2024
1		15 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 Drug	M028	08/01/2024

Labeler - WR Group Skin Care Ltd (592719822)