78500143-eacc-785b-e053-2991aa0ac206

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

Active Ingredient

Sulfur 8%, Resorcinol 2%

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 60561-8

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

Structured Label Content

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

Active Ingredient (55106-9)

Sulfur 8%, Resorcinol 2%

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

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 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