Calendula 5% Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:37

Label at a glance#

ProductCalendula 5% Special Order
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR Topical USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Use or as needed. Ages 12 and older: 2-3 sprays. Ages 2-11: 1-2 sprays. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100gm spray contain: 5gm Calendula 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, Sodium chloride, Tea tree oil, Grapefruit seed extract

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any
ingredient. Consult a doctor before use for
serious conditions or if conditions worsen or
persist. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seals on box are broken or missing.

SHAKE WELL BEFORE USE

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
www.urielpharmacy.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calendula5SOSprayCalendula5SOSpray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3215-2Calendula 5% Special Order30 mL in 1 BOTTLE, SPRAYSPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-3215CALENDULA 5% SPECIAL ORDER SPRAY [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20180508_6bb46614-a14c-a3dd-e053-2a91aa0a11c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-321548951-3215-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6bb46614-a14d-a3dd-e053-2a91aa0a11c46bb46614-a14c-a3dd-e053-2a91aa0a11c42018-05-08WarningsExact identifier
spl id: 6bb46614-a14d-a3dd-e053-2a91aa0a11c4
spl set id: 6bb46614-a14c-a3dd-e053-2a91aa0a11c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.