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 Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

• 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 immediately.

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, 4pk

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Bulk Patch

INGREDIENTS AND APPEARANCE

MEDICATED PAIN RELIEF 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0302
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: 67510-0302-4	4 in 1 CARTON
1		1 in 1 POUCH
2	NDC: 67510-0302-1	1 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/07/2011

Labeler - Kareway Product, Inc. (121840057)