Imman Coolbreeze: Package Insert and Label Information

IMMAN COOLBREEZE- menthol, unspecified form and methyl salicylate gel
Nwagu, Chidiobi Jeremy

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.

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.

Store in cool dry place

Packaging

image description
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IMMAN COOLBREEZE
menthol, methyl salicylate gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72744-777
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM 5 g in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
Product Characteristics
Color green Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72744-777-35 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 g in 1 BOTTLE This package is contained within the CARTON (72744-777-35)
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 Operations
Nwagu, Chidiobi Jeremy 083685493 manufacture (72744-777)

Revised: 11/2018 Nwagu, Chidiobi Jeremy

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