SPL v3
SPL
SPL Set ID 7747b738-cfb8-0cf2-e053-2991aa0a031e
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (10 g)
Inactive Ingredients
Phenoxyethanol Polyacrylamide (10000 Mw) Water Kaolin Bentonite Glycerin 2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-1,2-propanediol Magnesium Aluminum Silicate C13-14 Isoparaffin Laureth-7 Potassium Sorbate Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-26

Description

Active Ingredients: Sulfur 10%


Medication Information

Warnings and Precautions

Warnings: For External Use Only

Indications and Usage

Uses: treats acne and helps prevent new acne blemishes from forming

Dosage and Administration

Directions: apply thin coat over affe3cted area; leave on approximately 20 minutes until completely dry; rinse off with warm watre; use recommended toner to finish cleansing; purified water may be added for smoothr mask consistency

Description

Active Ingredients: Sulfur 10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Section 50567-7

When using this product: do not use in or near eyes, lips, and mouth

Section 50569-3

Consult a doctor: if excessive irritation occurs

Section 51727-6

Inactive Ingredients: Water, Kaolin, Bentonite, Glycerin, Propylene Glycol, Magnesium Aluminum Silicate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Potassium Sorbate, Ethyl hexylglycerin, Phenoxyethanol

Section 51945-4

Section 55105-1

acne mediaction; to treat and prevent acne

Section 55106-9

Active Ingredients: Sulfur 10%

Section 60561-8

Other information: store at room temperature; keep tightly closed


Structured Label Content

Indications and Usage (34067-9)

Uses: treats acne and helps prevent new acne blemishes from forming

Dosage and Administration (34068-7)

Directions: apply thin coat over affe3cted area; leave on approximately 20 minutes until completely dry; rinse off with warm watre; use recommended toner to finish cleansing; purified water may be added for smoothr mask consistency

Warnings and Precautions (34071-1)

Warnings: For External Use Only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Section 50567-7 (50567-7)

When using this product: do not use in or near eyes, lips, and mouth

Section 50569-3 (50569-3)

Consult a doctor: if excessive irritation occurs

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Kaolin, Bentonite, Glycerin, Propylene Glycol, Magnesium Aluminum Silicate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Potassium Sorbate, Ethyl hexylglycerin, Phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

acne mediaction; to treat and prevent acne

Section 55106-9 (55106-9)

Active Ingredients: Sulfur 10%

Section 60561-8 (60561-8)

Other information: store at room temperature; keep tightly closed


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)