SPL v6
SPL
SPL Set ID a2e83e97-28c3-5d10-e053-2995a90a72ea
Route
TOPICAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (30 g) Benzalkonium (0.624 g) Isopropyl Alcohol (75 g) Cetylpyridinium (0.1 g)
Inactive Ingredients
Propylene Glycol Isopropyl Alcohol Didecyldimonium Chloride Water Edetate Disodium Decyl Glucoside Anhydrous Citric Acid Chlorphenesin Glycerin Polysorbate 20 Iodopropynyl Butylcarbamate Bronopol Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-13


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51945-4

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)