Cool Breeze

Manufacturer
Cool Breeze US LLC
Effective date
2021-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:30

Label at a glance#

ProductCool Breeze
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure8 sections

Dosage and administration

Adults and children over 12 years: • Apply generously to affected area. • Massage into painful area until thoroughly absorbed into skin • Repeat as necessary, But no more than 4 times daily Children 12 years or younger: • Please speak with a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol  5.0%
Methyl Salicylate  4.0%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:
• Arthritis | Backache | Muscles | Strains | Sprains | Bruises | Cramps

Warning

WARNINGS SECTION

• Flammable keep away from fire or flame
• For external use only
• Store in cool dry place

When using this product - use only as directed
• Do not bandage tightly or use with a heating pad
• Avoid contact with eyes and mucus membranes
• Do not apply to wounds or damaged, broken or irritated skin
• A burning sensation may occur upon application but generally disappears

If gel comes in contact with eyes, wash with warm water

Stop use and ask a doctor if
• Condition worsens
• Symptoms persists for more than 7 days or pain continues to occur

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, In case of accidental ingestion, Get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

• Apply generously to affected area.
• Massage into painful area until thoroughly absorbed into skin
• Repeat as necessary, But no more than 4 times daily

Children 12 years or younger:
• Please speak with a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

A non-alkaline base with water and color.

SPL UNCLASSIFIED SECTION

FAST ACTING NATURAL PAIN RELIEF 

Distributed by
Cool Breeze US LLC
Indianapolis, IN

Designed in Nigeria
Manufactured in the USA
www.coolbreezeus.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cool breeze-778Cool breeze-778

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2105836menthol 5 % / methyl salicylate 4 % Topical GelPSN1
2105836menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Topical GelSCD1
2105836menthol 5 % / methyl salicylate 4 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72744-778-402024-01-30C16284748780-11030e365-3d8d-111a-e063-dadaa90a10e2COOL BREEZE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72744-778-40Cool Breeze113 g in 1 TUBEGEL1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72744-778COOL BREEZE (MENTHOL, METHYL SALICYLATE) GEL [COOL BREEZE US LLC]1Legacy NDC, 1 package rows20211209_8ed18295-01ff-4a63-8391-54bbb4be55a7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72744-77872744-778-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
d5d918eb-0f7d-415b-a019-cf5535996ac48ed18295-01ff-4a63-8391-54bbb4be55a72021-12-03WarningsExact identifier
spl id: d5d918eb-0f7d-415b-a019-cf5535996ac4
spl set id: 8ed18295-01ff-4a63-8391-54bbb4be55a7

Reported adverse events (FAERS/openFDA)#

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