MENTHO PATCH COOL- menthol patch

Mentho patch by

Drug Labeling and Warnings

Mentho patch by is a Otc medication manufactured, distributed, or labeled by THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INDICATIONS & USAGE

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

Product Label Outer Pack

INGREDIENTS AND APPEARANCE

MENTHO PATCH  COOL
menthol patch

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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)

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