Anti Acne Natural Volcanic Sulfur Soap
FDA Label NDC 26050-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pt. Galenium Pharmasia Laboratories for the product Anti Acne Natural Volcanic Sulfur (NDC 26050-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, use, warnings, when using this product, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Otc - Do Not Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions Or Comments

→ Principal Display Panel - 20 G Box

Other

Drug Facts

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

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.

Otc - Do Not Use

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.

Otc - Keep Out Of Reach Of Children

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.