FDA.reportPublic FDA data

CBD Cryotherapy Pain Relief Roll-On

Manufacturer
Global Widget, LLC | Global Widget LLC
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:18:41

Label at a glance#

ProductCBD Cryotherapy Pain Relief Roll-On
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of  pain

Dosage and administration

• Shake well before use • Adults 18 years & over rub a thin layer into affected areas up to 4 times daily.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP  4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of  pain

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Do not use:

OTC - DO NOT USE SECTION

  • On eyes or on mucous membranes
  • On wounds, damaged or irritated skin
  • If you are allergic to Menthol or any of the ingredients listed below

When using this product:

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with heating pad or devices, or apply external heat

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding: Do not use this product.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well before use
• Adults 18 years & over rub a thin layer into affected areas up to 4 times daily.

Other Information:

OTHER SAFETY INFORMATION

Store in cool, dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Carbomer, Pure CBD Extract, Triethanolamine

Distributed by

SPL UNCLASSIFIED SECTION

Global Widget, LLC

8419 Sunstate Street, Tampa, FL 33634

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURE'S

SCRIPT

CBD Cryotherapy Pain Relief Roll-On

MENTHOL 4%

3 FL OZ (89 mL)

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73423-005CBD CRYOTHERAPY PAIN RELIEF ROLL-ON (MENTHOL) GEL [GLOBAL WIDGET, LLC]5Legacy NDC20231212_0ed29aff-eb4e-4404-ac28-5f29f552c73a.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
73423-00573423-005-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
CANNABIDIOL19GBJ60SN5IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
0c498828-e0d8-d65a-e063-6394a90a14880ed29aff-eb4e-4404-ac28-5f29f552c73a2023-12-11WarningsExact identifier
spl id: 0c498828-e0d8-d65a-e063-6394a90a1488
spl set id: 0ed29aff-eb4e-4404-ac28-5f29f552c73a

Reported adverse events (FAERS/openFDA)#

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