IMMAN COOLBREEZE- menthol, methyl salicylate gel

Imman coolbreeze by

Drug Labeling and Warnings

Imman coolbreeze by is a Otc medication manufactured, distributed, or labeled by Nwagu, Chidiobi Jeremy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

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

Purpose

External analgesic

Uses

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

Warnings

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.

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

Directions

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:

A non-alkaline base with water and colour.

STORAGE AND HANDLING

Store in cool dry place

Packaging

INGREDIENTS AND APPEARANCE

IMMAN COOLBREEZE 
menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72744-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72744-777-35	1 in 1 CARTON	12/05/2018
1		100 g in 1 BOTTLE; 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	12/05/2018

Labeler - Nwagu, Chidiobi Jeremy (083685493)

Establishment
Name	Address	ID/FEI	Business Operations
Nwagu, Chidiobi Jeremy		083685493	manufacture(72744-777)