ANTI ACNE NATURAL VOLCANIC SULFUR- sulfur soap
PT. GALENIUM PHARMASIA LABORATORIES

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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Anti-Acne Soap Natural Volcanic Sulfur 10%

Drug Facts

Active Ingredients

Precipitated Sulfur 10%

Purpose

Acne medication

Use

for the treatment of acne.

Warnings

For external use only

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs , only use one topical acne medication at a time.
Apply only to areas with acne.

Do not use on broken skin.
Do not use on large areas of skin.
Do not get into eyes. If excessive skin Irritation develops or increases, discontinue use and consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Work up a lather using warm water and apply to affected area.
Rinse thoroughly and pat dry.
Because excessive drying of the skin 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.

Inactive ingredients

Saponified Palm and Palm Kernel Oil, Lanolin, Fragrance, Coconut Fatty Acid Diethanol Amide, Salicylic Acid 0.25%, Glycerin, Titanium Dioxide.

Questions or Comments

888-406-0151

Distributed by Dr. Joesoef Skin Care, LLC.
Boca Raton, Florida 33433 USA

PRINCIPAL DISPLAY PANEL - 20 g Box

SULFUR 10%

NEW!

Joesoef™
SKIN CARE

Anti-Acne Soap
Natural Volcanic Sulfur 10%

For Oily to Normal Skin

Formulated & Developed
by Dermatologists for:

• Treatment of Acne
• Clogged pores
• Blackheads
• Blemishes

Net wt. 0.7 oz (20g)

ANTI ACNE NATURAL VOLCANIC SULFUR
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:26050-101
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SALICYLIC ACID (UNII: O414PZ4LPZ)
PALM KERNEL OIL (UNII: B0S90M0233)
LANOLIN (UNII: 7EV65EAW6H)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:26050-101-02	20 g in 1 BOX; Type 0: Not a Combination Product	10/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/01/2012

Labeler - PT. GALENIUM PHARMASIA LABORATORIES (726631497)

Name	Address	ID/FEI	Business Operations
Establishment
Galenium Pharmasia Laboratories, PT		726631497	manufacture(26050-101)

Revised: 2/2020

Document Id: 9f6847c1-1fd0-99aa-e053-2a95a90ab9c0

Set id: 4f230abd-5c07-4121-81da-a9fa2d20a2ca

Version: 3

Effective Time: 20200225

PT. GALENIUM PHARMASIA LABORATORIES