MENTHO PATCH COOL- menthol patch
THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID

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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Menthopatch Cool

Purpose

For the temprorary releif of minor aches and pains of musceles and joints associated with simple backache, arthritis,strainsand sprains

Warnings

FOR EXTERNAL USE ONLY
When Using this Product
Avoid contact with eyes
Do not apply to open wounds, or to damaged skin
Do not bandage tightly.

Directions

Adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 3 years of age: consult doctor.

Stop use and ask doctor

If condition worsens
If symptoms persist more than 7 days or clear up and occur again with a few days

storage

store in cool dry place avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

Active ingridient section

Menthol,Camphor,Methyl salicylate

INACTIVE INGREDIENT SECTION

Glycerin ,Sodium poly acryl ate ,Aluminum chloride hex hydrate 2 ,
Anhydrous citric acid ,Tartaric acid 1 ,Poly sorbate -80 (tween 80) 0.5 ,Isopropyl myristate alcohol 2.5 ,Car boxy methyl cellulose (CMC) 2
EDETA 0.5 ,Polyvinyl pyrolidone(PVP-K90) 3 ,Water 48.35 ,titanium dioxide 0.05,ACRYLATE/ C10-30 ALKYL ACRYLATE,cross polymer

Product Label Inner Pack

Inner Pack

Product Label Outer Pack

Outer Pack

MENTHO PATCH COOL
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72602-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALUMINUM CHLORIDE ANHYDROUS (UNII: LIF1N9568Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TARTARIC ACID (UNII: W4888I119H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%) (UNII: ZY4732LP1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72602-002-01	10 g in 1 PATCH; Type 0: Not a Combination Product	09/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/20/2018

Labeler - THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID (850486280)

Registrant - THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID (850486280)

Name	Address	ID/FEI	Business Operations
Establishment
THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID		850486280	manufacture(72602-002)

Revised: 12/2021

Document Id: d2a2f568-8d6d-efd8-e053-2995a90a5357

Set id: 02251a4a-fc6f-42c9-a244-6f4835de5edd

Version: 4

Effective Time: 20211208

THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID