MENTHOPATCH HOT- menthol , capsicum extract 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.

----------

MenthoPatch Hot

Active Ingrdient

Menthol 4% 

Capsicum  Extract  5 % 

Purpose 

Temporarily relieves minor pain.

Warnings

  • For external use only
  • When using this product
  • Avoid contact with the eyes
  • Do not apply to wounds, or to damaged skin
  • Do not bandage tightly.
  • Consult doctor if pain continued after 7 days using product or excess skin inflamation.
  • Children under 12 years of age: consult doctor.

Direction 

  • Clean and dry the affected area.
  • Open the cover of product and peel of the transparent layer of the product.
  • Paste the product on affected area.
  • Menthol patch is effective up to 8 hours which can replaced as needed.

DOSAGE & ADMINISTRATION

  • use menthol patch from 2 to 3 days

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

Inactive ingredients

Glycerin 24 

Sodium poly acryl ate 8 
Aluminum chloride hexahydrate 
Citric acid 
Tartaric acid 
Polysorbate 80
Isopropyl myristate alcohol 2.5 
Car boxy methyl cellulose 
EDETA .2Na 0.5 
Polyvinyl pyrolidone(PVP-K90) 
Water 48
Titanium dioxide 
Methyl salicylate 
Camphor 
Hot act vbe 0.2
ACRYLATE/ C10-30 ALKYL ACRYLATE cross polymer

Carton

image descriptionimage description

MENTHOPATCH  HOT
menthol , capsicum extract patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72602-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM50 mg
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol40 mg
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
titanium dioxide (UNII: 15FIX9V2JP)  
Methyl salicylate (UNII: LAV5U5022Y)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72602-001-015 in 1 PACKAGE10/10/2018
11 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/21/201810/25/2018
Labeler - THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID (850486280)
Registrant - THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID (850486280)
Establishment
NameAddressID/FEIBusiness Operations
THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID850486280manufacture(72602-001)

Revised: 10/2018
 
THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID