MUSCLE RUB ULTRA- camphor,menthol, methyl salicylate cream

Muscle Rub Ultra by

Drug Labeling and Warnings

Muscle Rub Ultra by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

                       

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Uses

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

• simple bachache
• 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 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 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 20° to 25°C (68°to 77°F)

Inactive Ingredients

carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Questions?

call 1-800-883-0085, weekdays, 9AM -5PM PST

PRINCIPAL DISPLAY PANEL

Muscle Rub Ultra

PURPOSE

Topical analgesic

Topical analgesic

Topical analgesic

INGREDIENTS AND APPEARANCE

MUSCLE RUB ULTRA 
camphor,menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0659
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	10 g  in 100 g
Menthyl Salicylate (UNII: 43XOA705ZD) (Menthyl Salicylate - UNII:43XOA705ZD)	Menthyl Salicylate	30 g  in 100 g
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0659-4	1 in 1 BOX
1		113 g in 1 TUBE
2	NDC: 51141-0659-1	1 in 1 BOX
2		65 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/16/2010

Labeler - NeoPharm Co., Ltd. (631101883)

Registrant - NeoPharm Co., Ltd. (631101883)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture