MUSCLE RUB- menthol, unspecified form and methyl salicylate cream

Muscle Rub by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 10%

Methyl Salicylate 15%

PURPOSE

Topical analgesic

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 wounds 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 membrane
• 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 to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• Use only as directed
• 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 15° to 25 °C (59° to 77°F)
• Lot No. & Exp. Date : See box or see crimp of tube

INACTIVE INGREDIENTS

Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

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 Rub
ULTRA STRENGTH

Pain Relieving Cream
Non-Greasy

NET WT.
3 OZ. (85g)

INGREDIENTS AND APPEARANCE

MUSCLE RUB 
menthol, unspecified form and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-015
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	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
LANOLIN (UNII: 7EV65EAW6H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-015-15	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(50382-015) , manufacture(50382-015) , pack(50382-015) , repack(50382-015) , sterilize(50382-015)