SOMXL by WR Group Skin Care Ltd

Drug Details [pdf]

SOMXL- salicylic acid solution
WR Group Skin Care Ltd

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M028	08/01/2024

Labeler - WR Group Skin Care Ltd (592719822)

Revised: 8/2024

Document Id: 1ef652bd-6c4b-846e-e063-6394a90a9fd9

Set id: 7122eab1-c56b-440c-b853-62ae9dfede97

Version: 5

Effective Time: 20240805

Trademark Results [SOMXL]

Mark Image Registration \| Serial	Company Trademark Application Date
SOMXL 88263531 not registered Live/Pending	McKinnon, Blair David 2019-01-16