SPL v1
SPL
SPL Set ID 44fa5eed-93e2-cb3a-e063-6294a90a3b04
Route
TOPICAL
Published
Effective Date 2025-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 g)
Inactive Ingredients
Peg-120 Methyl Glucose Dioleate Phenoxyethanol Matricaria Chamomilla Flowering Top Oil Sodium Chloride Sodium Benzoate Polyquaternium-10 (1400 Mpa.s At 2%) Water Aminomethyl Propanol Benzoic Acid Coco-glucoside Ethylhexylglycerin Isopropyl Alcohol Potassium Sorbate Edetate Disodium Aloe Barbadensis Leaf Juice Betaine Peppermint Oil Glycerin Sodium Lauroyl Sarcosinate Citric Acid Glycereth-2 Cocoate Hydroxypropyl Guar Hydroxypropyltrimonium Chloride Polyquaternium-7 Almond Oil Sodium Hydroxide Sodium Acetate Cocamidopropyl Hydroxysultaine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-25


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)