SPL v2
SPL
SPL Set ID 049e4a9b-3e4f-a3f4-e063-6294a90a302c
Route
TOPICAL
Published
Effective Date 2023-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.725 mg)
Inactive Ingredients
Levomenol Octyldodecanol Water Polyhydroxystearic Acid (2300 Mw) Isododecane Butyloctyl Salicylate Glycerin Propanediol Sodium Chloride Hydroxyacetophenone Propylene Carbonate Potassium Sorbate Cannabidiol Xanthan Gum Rosemary Anhydrous Citric Acid Helianthus Annuus Flowering Top Tocopherol Alkyl (c12-15) Benzoate Cannabis Sativa Seed Oil Coco-caprylate/caprate Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Stearoyl Glutamic Acid Sodium Benzoate Rice Bran Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Stearalkonium Hectorite Castor Oil Calcium Gluconate Medium-chain Triglycerides Triheptanoin Lingonberry Dilinoleic Acid/butanediol Copolymer Glycyrrhizinate Dipotassium C9-12 Alkane Gluconolactone Calendula Officinalis Flower

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-09-05

Description

X


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Description

X

Section 43683-2

X

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 43683-2 (43683-2)

X

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)