MUSCLE AND JOINT- menthol gel

Muscle and Joint by

Drug Labeling and Warnings

Muscle and Joint 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 2.5%

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains
  

WARNINGS

For external use only

Do not use

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

Ask a doctor before use 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

• 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:  ask a doctor
  

Other information

• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

Purpose

Topical analgesic

Package label

Muscle and joint pain relief rub

INGREDIENTS AND APPEARANCE

MUSCLE AND JOINT 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0005-4	1 in 1 BOX	08/11/2011
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67510-0005-2	1 in 1 BOX	08/11/2011
2		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/11/2011

Labeler - Kareway Product, Inc. (121840057)