Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Use

temporarily relieves minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- bruises
- sprains

Warnings

For external use only

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Ask a doctor before using if you have

redness over the affected area

When using this product

avoid contact with eyes or mucous membranes
do not bandage tightly

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Keep out of reach of children.

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

Directions

open pouch and remove patch
if desired, cut patch to size
peel off protective backing and apply sticky side to affected area
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: consult a doctor

Other information

store at 20° to 25°C (68°F to 77°F)

Inactive ingredients

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carboxymethylcellulose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide

package label

Pain Relieving Patch image of carton label

MEDICATED PAIN RELIEF
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-911
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	428.5 mg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description
Packaging
1	NDC:41520-911-04	4 in 1 CARTON
1		1 in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/16/2011

Labeler - American Sales Company (809183973)

Drug Facts