ALIVIO MEDICATED PAIN- menthol, capsaicin patch 
Alivio Medical Products, LLC

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.

----------

Alivio Medicated Pain Patch

Drug Facts

Active ingredient

Menthol 5.00%

Capsacin 0.03%

Purpose

External Analgesic

External Analgesic

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings:

Do not

  • apply to open wounds or damages skin.
  • bandage tightly
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children

If swallwed, consult physician.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Other Ingredients:

acrylic acid ,aluminum hydroxide .carmellose sodium 2-ethylhexyl acrylate .glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .polyacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate starch .talc .tartaric acid. titanium dioxide. water (245-114)

Store

at room temperature.  Avoid direct sunlight

Package Label

Alivio Patch

MEDICATED PAIN PATCH

15 PATCHES

Distributed by:

Alivio Medical Products

Hollywood, FL 33020

AlivioPatch2

ALIVIO MEDICATED PAIN 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69512-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.03 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69512-001-0115 in 1 BOX
18.5 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/21/2015
Labeler - Alivio Medical Products, LLC (079670828)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co.,Ltd421295875manufacture(69512-001)

Revised: 1/2015
Document Id: ec16ea66-f03c-4a36-8e1b-40b6fb04a2aa
Set id: 0748463a-b3e4-4c22-aa98-98c54e86debb
Version: 1
Effective Time: 20150121
 
Alivio Medical Products, LLC