SOMXL- salicylic acid solution 
WR Group Skin Care Ltd

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SOMXL

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:

Label

SOMXL 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70463-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID170 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
ETHYL LACTATE (UNII: F3P750VW8I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70463-000-011 in 1 BOX06/26/202306/26/2023
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02806/26/202306/26/2023
Labeler - WR Group Skin Care Ltd (592719822)

Revised: 5/2024
Document Id: 19225b18-7b55-fa98-e063-6294a90a093e
Set id: 7122eab1-c56b-440c-b853-62ae9dfede97
Version: 4
Effective Time: 20240523
 
WR Group Skin Care Ltd