SOUNDBODY- lidocaine, menthol patch

Soundbody by

Drug Labeling and Warnings

Soundbody by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Menthol 1%

Purposes

Topical Anesthetic

Topical Analgesic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When Using This Product

• use only as directed. Read and follow all directions and warnings on this label.
• rare cases of serious burns have been reported with products of this type
• do not apply to wounds or damaged, broken or irritated skin
• do not allow contact with the eyes and mucous membranes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use and Ask a Doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• use 2 patch for up to 24 hours

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

• Desensitizes Aggravated Nerves
• Dual Action with Lidocaine and Menthol
• Fast Acting and Long Lasting
• First Aid for Pain

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

INGREDIENTS AND APPEARANCE

SOUNDBODY 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0636
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0636-1	1 in 1 POUCH; Type 0: Not a Combination Product	05/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/02/2018

Labeler - Kareway Product, Inc. (121840057)