FDA.reportPublic FDA data

Imman coolbreeze

Manufacturer
Nwagu, Chidiobi Jeremy
Effective date
2018-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:44:21

Label at a glance#

ProductImman coolbreeze
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure8 sections

Indications and uses

temporarily relieves minor pain associated with: • arthritis • backache • muscle • strains • sprains • bruises • cramps

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 not more than 3 or 4 times daily • IF MEDICINE COMES IN CONTACT WITH EYES, WASH WITH SOAP AND WATER. children 12 years or younger: ask doctor

Storage and handling

Store in cool dry place

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol........................5.0%
Methyl Salicylate...........4.0%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:
• arthritis • backache • muscle • strains • sprains • bruises • cramps

Warnings

WARNINGS SECTION

Flammable keep away from fire or flame

For external use only

When using this product • use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

a transient burning sensation may occur upon application but generally disappears

Stop use and ask a doctor if

• condition worsens • redness is present • irritation develops • symptoms persist for than • 7 days or clear up and occur again within a few days

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 not more than 3 or 4 times daily

• IF MEDICINE COMES IN CONTACT WITH EYES, WASH WITH SOAP AND WATER.

children 12 years or younger: ask doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

A non-alkaline base with water and colour.

STORAGE AND HANDLING SECTION

Store in cool dry place

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
72744-77772744-777-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT

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
cf86b2a1-10d6-4d32-bb7f-cb356b233adbb6886198-6794-4f23-aac6-7520b8a38c4e2021-06-29WarningsExact identifier
spl set id: b6886198-6794-4f23-aac6-7520b8a38c4e

Reported adverse events (FAERS/openFDA)#

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