Overnight Spot Treatment

SPL v6

SPL

SPL Set ID 23bde802-d84a-1ecc-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2015-11-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sulfur (100 mg)

Inactive Ingredients

Isopropyl Alcohol Zinc Oxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-11-04

Description

Acne Treatment

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Acne Treatment

Dosage and Administration

Topical

Description

Acne Treatment

Section 50565-1

Keep out of reach of children.

Section 51727-6

Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

Sulfur 10%

Structured Label Content

Indications and Usage (34067-9)

Acne Treatment

Dosage and Administration (34068-7)

Topical

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Sulfur 10%

Advanced Ingredient Data

[{"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Acne Treatment", "34068-7": "Topical", "34071-1": "For external use only", "50565-1": "Keep out of reach of children.", "51727-6": "Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.", "55105-1": "Acne Treatment", "55106-9": "Sulfur 10%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.490318 · Updated: 2026-03-14T23:10:26.709421