FDA.reportPublic FDA data

Cooling Pain Relief 3% Menthol Cream

Manufacturer
Bluebird Botanicals | Royal Labs Natural Cosmetics, Inc.
Effective date
2021-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:53

Label at a glance#

ProductCooling Pain Relief 3% Menthol Cream
Active ingredientMENTHOL
Label structure8 sections

Storage and handling

Store in a cool dry place with lid closed tightly.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%

OTC - PURPOSE SECTION

Menthol 3%......................Topical Analgesic

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use:

  • on wounds or damaged skin
  • on mouth or eyes
  • with a heating pad
  • on genitals or any other mucous membrane
  • if condition worsens

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • irritation occurs
  • symptoms persist for more than 7 days, or clear up and recur

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults 18 years of age and older: Apply one pump (serving) directly onto affected area 3 to 4 times daily; Children under 18 years of age ask a doctor.

STORAGE AND HANDLING SECTION

Store in a cool dry place with lid closed tightly.

INACTIVE INGREDIENT SECTION

Aqua, Shea (Butyrospermum Parkii) Butter, Cetearyl Glucoside, Cetearyl Alcohol, Glyceryl Stearate Citrate, CBD (Cannabidiol) Isolate (from hemp (Cannabis sativa)), Organic Aloe Vera (Aloe Barbadensis) Leaf Juice, Tapioca Starch, Glycerin, Caprylic/Capric Triglyceride, Xanthan Gum, Organic Rosemary (Rosmarinus Officinalis) Leaf Extract, Organic Arnica (Arnica Spp.) Extract, Glyceryl Caprylate, Caprylhydroxamic Acid, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bluebird Botanicals

Cooling Pain Relief

3% Menthol Cream

CBD: 10 mg Per Pump

CBD: 500 mg Per Bottle

Net wt. 1.7 oz (50 mL)

Made with moisturizing Shea Butter, Aloe & CBD*

11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81525-00181525-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CANNABIDIOL19GBJ60SN5IACT
GLYCERINPDC6A3C0OXIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ARNICA MONTANAO80TY208ZWIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
ALOE VERA LEAFZY81Z83H0XIACT
STARCH, TAPIOCA24SC3U704IIACT
TRICAPRINO1PB8EU98MIACT
ROSEMARYIJ67X351P9IACT
MENTHOLL7T10EIP3AACTIB

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
d34f59ab-ab75-48b2-e053-2a95a90ada0bbd496670-8c63-4f17-e053-2a95a90a76f12021-12-16WarningsExact identifier
spl set id: bd496670-8c63-4f17-e053-2a95a90a76f1

Reported adverse events (FAERS/openFDA)#

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