FDA.reportPublic FDA data

CannaCalming massage oil

Manufacturer
Carolina Cannabis Creations L.L.C
Effective date
2022-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:53:20

Label at a glance#

ProductCannaCalming massage oil
Active ingredientARNICA MONTANA FLOWER WATER
Label structure9 sections

Indications and uses

temporary relief of aches and pains associated with arthritis, backache, muscle pains, joint pain, bruising Topical analgesic Topical analgesic

Dosage and administration

shake well before use. adults and children 12 years and over; apply to affected area 1-4 times daily. children under 12 years; consult a doctor Keep out of reach of children

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 2.53%

Mentha arvensis (peppermint) oil <1%

Uses

INDICATIONS & USAGE SECTION

temporary relief of aches and pains associated with arthritis, backache, muscle pains, joint pain, bruising

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Topical analgesic

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Do not apply to wounds or irritated skin, avoid contact with eyes, if you are allergic to the listed ingredients

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs

Stop use and ask doctor if

OTC - STOP USE SECTION

Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a health professional before use.

in case of overdose

OVERDOSAGE SECTION

seek medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use.

adults and children 12 years and over; apply to affected area 1-4 times daily.

children under 12 years; consult a doctor

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

inactive ingredients

INACTIVE INGREDIENT SECTION

oryza sativa (rice bran) oil, Prunus dolcis (sweet almond) oil, simmondsia chinensis (jojoba) oil, Cannabidol, lavendula agustifolia (lavender) oil.

label change

RECENT MAJOR CHANGES SECTION

changed indications and usage to dosage and administration

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

massage oil labelmassage oil label

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82876-43782876-437-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
RICE BRAN OILLZO6K1506AIACT
LAVENDER OILZBP1YXW0H8IACT
PEPPERMINT OILAV092KU4JHIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRACTIB
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
CANNABIDIOL19GBJ60SN5IACT

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
01ccdcb1-7fd2-a650-e063-6394a90aaa69e706767a-14f8-4c59-e053-2a95a90ad8952023-07-31WarningsExact identifier
spl set id: e706767a-14f8-4c59-e053-2a95a90ad895

Reported adverse events (FAERS/openFDA)#

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