JOESOEF SKINCARE ANTI ACNE- sulfur lotion

Joesoef Skincare Anti Acne by

Drug Labeling and Warnings

Joesoef Skincare Anti Acne by is a Otc medication manufactured, distributed, or labeled by PT Galenium Pharmasia Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients                     Purpose

Precipitated Sulfur 6.6%..............Acne medication

PURPOSE

Use for the treatment of acne. Penetrades pores to clear most acne blemishes, acne pimples, blackhead, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 

In case of incidental ingestion, get medical help or contact a poison control center immediately.

INDICATIONS & USAGE

Directions

• Cleanse the skin thoroughly before applying medication.
• Using a cotton swab, cover the entire effected area with a thin layer one to three times daily.
• Because excessive drying of the skim may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• Shake well before use

WARNINGS

Warnings

For external use only

DOSAGE & ADMINISTRATION

When using this product

• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• Do not get into eyes. If excessive skin irridation develops or increases, discontinue use and consult a doctor.

INACTIVE INGREDIENT

Inactive ingredients

Purified water, Ethyl alcohol, DMDM Hydantoin, Cabomer, Fragrance, Triethanolamine, Calcium oxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JOESOEF SKINCARE ANTI ACNE 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26050-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6.3   in 95 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CARBOMER 1342 (UNII: 809Y72KV36)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26050-112-01	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/01/2006

Labeler - PT Galenium Pharmasia Laboratories (726631497)

Establishment
Name	Address	ID/FEI	Business Operations
PT Galenium Pharmasia Laboratories		726631497	manufacture(26050-112)