04b1a617-e187-9f04-e063-6394a90a7c9c

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

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1


Structured Label Content

Warnings and Precautions (34071-1)

Active Ingredient (55106-9)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)