SPL v1
SPL
SPL Set ID cb93fd98-bea8-39dd-e053-2a95a90ac962
Route
TOPICAL
Published
Effective Date 2021-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Edetate Disodium Sodium Citrate Butylene Glycol Caprylyl Glycol Oleanolic Acid Hydroxyethyl Cellulose, Unspecified Alcohol Levomenol Carboxypolymethylene Water Glycerin Tetrahexyldecyl Ascorbate Sodium Hydroxide Peg-8/smdi Copolymer Saccharide Isomerate Citric Acid Monohydrate Peg-60 Almond Glycerides Allantoin Polyoxyl 40 Hydrogenated Castor Oil Dimethyl Isosorbide Nordihydroguaiaretic Acid, (+/-)-

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-09-09


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

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 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)