MALIN AND GOETZ ACNE TREATMENT- sulfur cream

Malin and Goetz by

Drug Labeling and Warnings

Malin and Goetz by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient purpose

Sulfur 10% Acne Treatment

Uses

treats acne

dries up acne pimples

helps prevent acne pimples

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

Warnings

For External Use only

Do not use on Broken Skin

When using this product

-Apply to affected areas only

-do not use in or near the eyes

-using other topical acne medication at the same time or right after the use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.

Directions

-do not shake solution

-lean the skin thoroughly before applying

-dip clean cotton swab into sediment and apply directly to blemishes

-because too much drying of the skin may occur, start with 1 application daily then gradually increase to 2 or 3 daily if needed or as directed by a doctor

-if bothersome drying or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

(Malin + Goetz)

acne treatment Nighttime

10% Sulfur lotion. Overnight Treatment

.5 fl. oz. 14ml

INGREDIENTS AND APPEARANCE

MALIN AND GOETZ  ACNE TREATMENT
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
SALICYLIC ACID (UNII: O414PZ4LPZ)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-010-02	1 in 1 CARTON	11/05/2012
1	NDC: 53634-010-01	14.75 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/05/2012

Labeler - Malin and Goetz Inc (138615930)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(53634-010)