SPL v1
SPL
SPL Set ID 78500143-eacc-785b-e053-2991aa0ac206
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (8 g) Resorcinol (2 g)
Inactive Ingredients
Glycerin Sodium Hydroxide Potassium Sorbate Phenoxyethanol Ethylhexylglycerin Water Dipropylene Glycol Carbomer 934

Identifiers & Packaging

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

Sulfur 8%, Resorcinol 2%

Medication Information

Warnings and Precautions

Warnings: For External Use Only; When using this product keep out of eyes, if contact occurs, flush thoroughly with water

Indications and Usage

Treats acne and helps prevent new acne blemishes from forming

Dosage and Administration

Use 1 to 3 times daily on cleansed skin; cover affected area with thin layer; follow with moisturizer

Description

Sulfur 8%, Resorcinol 2%

Section 50565-1

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

Section 51727-6

Water, Glycerine, Propylene Glycol, Carbomer 940, Sodium Hydroxide, Potassium Sorbate, Phenoxyethanl, Ethylhexylglycerin

Section 51945-4

Section 55105-1

Acne treatment and antiseptic

Section 55106-9

Sulfur 8%, Resorcinol 2%

Section 60561-8

If bothersome, dryness or peeling occurs, reduce application to once a day.

Structured Label Content

Indications and Usage (34067-9)

Treats acne and helps prevent new acne blemishes from forming

Dosage and Administration (34068-7)

Use 1 to 3 times daily on cleansed skin; cover affected area with thin layer; follow with moisturizer

Warnings and Precautions (34071-1)

Warnings: For External Use Only; When using this product keep out of eyes, if contact occurs, flush thoroughly with water

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Glycerine, Propylene Glycol, Carbomer 940, Sodium Hydroxide, Potassium Sorbate, Phenoxyethanl, Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne treatment and antiseptic

Section 55106-9 (55106-9)

Sulfur 8%, Resorcinol 2%

Section 60561-8 (60561-8)

If bothersome, dryness or peeling occurs, reduce application to once a day.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:02.605125 · Updated: 2026-03-14T22:55:53.187482