MUSCLE AND JOINT- menthol, unspecified form gel

Muscle and Joint by

Drug Labeling and Warnings

Muscle and Joint by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Menthol 2.5%

PURPOSE

Topical Analegesic

USES

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

WARNINGS

For External Use Only.

Do not use

• On wounds or damaged skin
• With a heating pad
• On children 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

Keep out of Reach of Children. If swallowed, get medical help of contact a Poison Control Center immediately.

DIRECTIONS

• Adults 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 between 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT

Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

SPL UNCLASSIFIED SECTION

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

Gandhidham-370 230, Gujarat. India

PRINCIPAL DISPLAY PANEL 85 g Tube Carton

Galentic

Muscle & Joint
VANISHING SCENT GEL

Quick Relief

NET WT.
3 OZ. (85g)

INGREDIENTS AND APPEARANCE

MUSCLE AND JOINT 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
POLYSORBATE 60 (UNII: CAL22UVI4M)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-016-15	1 in 1 CARTON	06/01/2012
1		85 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	06/01/2012

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-016) , manufacture(50382-016) , pack(50382-016) , repack(50382-016) , sterilize(50382-016)