SPL v1
SPL
SPL Set ID 04b1a617-e187-9f04-e063-6394a90a7c9c
Route
TOPICAL
Published
Effective Date 2023-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (2.3175 g)
Inactive Ingredients
Cannabidiol Rosemary .alpha.-tocopherol Lingonberry Calcium Gluconate Water Isododecane Polyhydroxystearic Acid (2300 Mw) Stearalkonium Hectorite Potassium Sorbate Coco-caprylate/caprate C9-12 Alkane Propylene Carbonate Octyldodecanol Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Glycerin Calendula Officinalis Flower Sodium Benzoate Glycyrrhizinate Dipotassium Castor Oil Rice Bran Triheptanoin Dilinoleic Acid/butanediol Copolymer Helianthus Annuus Flowering Top Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Cannabis Sativa Seed Oil Stearoyl Glutamic Acid Hydroxyacetophenone Xanthan Gum Gluconolactone Butyloctyl Salicylate Medium-chain Triglycerides Propanediol Sodium Chloride Levomenol Citric Acid Monohydrate Alkyl (c12-15) Benzoate

Identifiers & Packaging

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


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)