Ptr 13-01-107 Sulfur Mask 5oz, 1.7oz And 0.5oz (jjl# Ref = Formula 31-16-1 V6)

Ptr 13-01-107 Sulfur Mask 5oz, 1.7oz And 0.5oz (jjl# Ref = Formula 31-16-1 V6)
SPL v1
SPL
SPL Set ID 308ec305-dbf3-c6f9-e063-6294a90a14ec
Route
TOPICAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (14.458 g)
Inactive Ingredients
Carbomer Phenoxyethanol Benzyl Acetate Water Polysorbate 20 Sodium Benzoate Hexamethylindanopyran Amyl Salicylate Ethylhexylglycerin Anisaldehyde Heliotropine Bentonite Potassium Sorbate Sodium Hyaluronate Linalool Aloe Barbadensis Leaf Juice Propylene Glycol Citronellol Kaolin Benzyl Salicylate Linalyl Acetate Phenylethyl Alcohol Triethoxycaprylylsilane Titanium Dioxide Terpineol Acetate Limonene, (+)- Glycerin Citric Acid Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01
Description

SULFUR 10%................................................................Acne Treatment

Medication Information

Warnings and Precautions

WARNINGS

For external use only.

Indications and Usage

USES

  • For the treatment and management of acne.
  • Clears up active acne blemishes and blackheads.
  • Helps to prevent new acne blemishes and blackheads.
Dosage and Administration

Directions

  • Clean skin. Apply to affected areas of face, chest and back.
  • Allow mask to dry for 5-10 minutes and rinse thoroughly with water to remove.
  • Pat dry.
  • Apply 2-3 times per week.
  • If bothersome dryness or peeling occurs, reduce frequency of application
  • Mask may dry out over time, add a few drops of water if needed.

Description

SULFUR 10%................................................................Acne Treatment

Section 50565-1

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

Section 50567-7

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

Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use abd consult a doctor.

Section 50570-1

Do not use on

  • Broken skin
  • Large areas of the skin
Section 51727-6

Inactive Ingredients

Water/Aqua/eau, Propylene Glycol, Glycerin, Bentonite, Kaolin, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Zinc Oxide, Phenoxyethanol, Carbomer, Polysorbate 20, Potassium Sorbate, Sodium benzoate, triethoxycaprylylsilane, Fragrane/Parfum, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin.

Section 51945-4

Section 53413-1

Questions or Comments?

Call toll free 1-800-PTR-SKIN (787-7546)

Section 55105-1

Sulfur 10%..................................................................................Acne treatment

Section 55106-9

SULFUR 10%................................................................Acne Treatment

Structured Label Content

Indications and Usage (34067-9)

USES

  • For the treatment and management of acne.
  • Clears up active acne blemishes and blackheads.
  • Helps to prevent new acne blemishes and blackheads.
Dosage and Administration (34068-7)

Directions

  • Clean skin. Apply to affected areas of face, chest and back.
  • Allow mask to dry for 5-10 minutes and rinse thoroughly with water to remove.
  • Pat dry.
  • Apply 2-3 times per week.
  • If bothersome dryness or peeling occurs, reduce frequency of application
  • Mask may dry out over time, add a few drops of water if needed.

Warnings and Precautions (34071-1)

WARNINGS

For external use only.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use abd consult a doctor.

Section 50570-1 (50570-1)

Do not use on

  • Broken skin
  • Large areas of the skin
Section 51727-6 (51727-6)

Inactive Ingredients

Water/Aqua/eau, Propylene Glycol, Glycerin, Bentonite, Kaolin, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Zinc Oxide, Phenoxyethanol, Carbomer, Polysorbate 20, Potassium Sorbate, Sodium benzoate, triethoxycaprylylsilane, Fragrane/Parfum, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 1-800-PTR-SKIN (787-7546)

Section 55105-1 (55105-1)

Sulfur 10%..................................................................................Acne treatment

Section 55106-9 (55106-9)

SULFUR 10%................................................................Acne Treatment

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:44.656119 · Updated: 2026-03-14T23:08:01.024401