SOUNDBODY- lidocaine, menthol patch 
Kareway Product, Inc.

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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Soundbody Lidocaine Plus Menthol Patch

Active ingredient

Lidocaine 4%

Menthol 1%

Purposes

Topical Anesthetic

Topical Analgesic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

When Using This Product

Stop Use and Ask a Doctor if

If Pregnant or Breast-Feeding

ask a health professional before use.

Keep Out of Reach of Children and Pets

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

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive Ingredients

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid,

propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

Package/Label Principal Display Panel

Pure-Aid

MAXIMUM STRENGTH

LIDOCAINE PATCH

PLUS MENTHOL

Targeted Immediate Pain Relief

Pain Relieving Ointment

on a Breathable Adhesive Pad

Contains 1 Patch



3-15/16” x 5-1/2” (10 cm x 14 cm) each

Label

label

SOUNDBODY 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0636
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
KAOLIN (UNII: 24H4NWX5CO)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0636-11 in 1 POUCH; Type 0: Not a Combination Product05/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/02/2018
Labeler - Kareway Product, Inc. (121840057)

Revised: 5/2018
Document Id: 6c83ec36-3e3e-07a9-e053-2a91aa0ac54c
Set id: 6c83ec36-3e3d-07a9-e053-2a91aa0ac54c
Version: 1
Effective Time: 20180518
 
Kareway Product, Inc.