FACEMATTER- sulfur lotion
Cosmed, Inc.

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.

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Clinicians Complex Acne Drying Lotion

Active Ingredients:

Sulfur 10%

Purpose

Acne Treatment

Uses:

Dries up acne pimples • Dries and clears acne blemishes • Helps keep skin clear of new acne blemishes

Warnings:

For external use only • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. • If this occurs, only one medication should be used unless directed by your doctor. Avoid contact with eyes. • If excessive irritation develops or increases, discontinue use and consult a doctor.

Keep out of reach of children.

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

Directions:

DO NOT SHAKE SOLUTION • Cleanse the skin thoroughly before applying medication • Dip clean cotton swab into sediment and apply directly to blemishes. Because excessive drying of the skin may occur, limit use to one application daily, or as directed by a physician.

Inactive Ingredients:

Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

Facematter Acne Solution Label

FACEMATTER
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61352-002
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ZINC OXIDE (UNII: SOI2LOH54Z)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61352-002-01	31.0 g in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/11/2013	12/04/2015

Labeler - Cosmed, Inc. (967008038)

Registrant - A.I.G. Technologies, Inc. (171837367)

Name	Address	ID/FEI	Business Operations
Establishment
A.I.G. Technologies, Inc.		171837367	manufacture(61352-002) , label(61352-002)

Revised: 8/2014

Document Id: d48988ac-b15d-47f5-8f50-a0af3957d925

Set id: 01fad35e-8c1f-4411-951c-15a6c686f234

Version: 2

Effective Time: 20140804

Cosmed, Inc.