LIDOTHAL RELIEF- menthol, lidocaine patch 
19 And Pacific, 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.

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Drug Facts

Active Ingredient

Menthol  1.00%

Lidocaine 4.00%

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:

Keep out of reach of children. If swallowed, consult physician.

Directions:

Store at room temperature. Avoid direct sunlight.

Other Ingredients:

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

nonoxynol-30 .poluacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate strach .talc .tartaric acid

.titanium dioxide .water(254-114)

image description

LIDOTHAL RELIEF 
menthol, lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71437-463
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 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:71437-463-1515 in 1 BOX07/31/2017
18.5 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2017
Labeler - 19 And Pacific, Llc (080619263)
Establishment
NameAddressID/FEIBusiness Operations
19 And Pacific, Llc080619263label(71437-463) , pack(71437-463)

Revised: 7/2017
Document Id: 4566aa43-ea37-4d48-a82c-55a61f81df05
Set id: da820c3c-2a4a-4dd5-a872-bb14ec9f4e1a
Version: 1
Effective Time: 20170731
 
19 And Pacific, Llc