CBD Heat Relief by Global Widget, LLC Drug Facts

CBD Heat Relief by

Drug Labeling and Warnings

CBD Heat Relief by is a Otc medication manufactured, distributed, or labeled by Global Widget, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CBD HEAT RELIEF- methyl salicylate spray 
Global Widget, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Methyl Salicylate  6%

Purpose

Topical Analgesic

Uses

For the temporary relief of  pain

Warnings

FOR EXTERNAL USE ONLY

Do not use:

• On eyes or on mucous membranes
• On wounds, damaged or irritated skin
• If you are allergic to Methyl Salicylate, Aspirin, Ibuprofen, any other inflammatory  ingredient or the ingredients listed below

When using this product:

• 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
• Do not inhale
• Do not consume this product

Stop use and ask a doctor if

• 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

If pregnant or breastfeeding: Do not use this product.

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

Directions

• Shake well before use
• Adults 18 years & over apply to affected areas
• How to apply: Spray 3 or 4 times per day as needed on the affected area and wash hands  immediately after use

Other Information:

Store in cool, dry place away from direct sunlight. Store at 68° - 77°F (20° - 25°C).

Keep away from flame

Inactive Ingredients

Ethyl Salicylate, Isopropyl Alcohol, Ricinoleic Acid (Castor Oil), Pine Oil, Glycerin, Peppermint Oil, Spiraea Ulmaria Extract (Meadowsweet), Vanillyl Butyl Ether, Polysorbate 80, Pure CBD Extract

Distributed by

Global Widget, LLC

8419 Sunstate Street, Tampa, FL 33634

Principal Display Panel

HEMP

BOMBS

CBD Heat Relief Spray

METHYL SALICYLATE 6%

2 FL OZ (59 mL)

CBD HEAT RELIEF 
methyl salicylate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73423-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYL SALICYLATE (UNII: 555U6TZ2MV)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE PINE OIL (UNII: HA5CX6676U)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CANNABIDIOL (UNII: 19GBJ60SN5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73423-008-01	6 in 1 PACKAGE	01/04/2021	01/31/2022
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/04/2021	01/31/2022

Labeler - Global Widget, LLC (089584863)

Establishment
Name	Address	ID/FEI	Business Operations
Global Widget, LLC		089584863	manufacture(73423-008)

Revised: 12/2021

Document Id: d288d2ce-0e4c-abd7-e053-2995a90a32f8

34390-5

Set id: 9aaa4bea-f241-4f75-894f-4c65100b77d1

Version: 2

Effective Time: 20211206