MEDICATED PAIN RELIEF- menthol patch

Medicated Pain Relief by

Drug Labeling and Warnings

Medicated Pain Relief by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MEDICATED PAIN RELIEF 
menthol patch

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - American Sales Company (809183973)