RITE AID ULTRA STRENGTH MUSCLE RUB- menthol, camphor, and methylsalicylate ointment

Rite Aid Ultra Strength Muscle Rub by

Drug Labeling and Warnings

Rite Aid Ultra Strength Muscle Rub by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Camphor 4%......................................................External Analgesic
Menthol 10%......................................................External Analgesic
Methyl Salicylate 30%.........................................External Analgesic

PURPOSE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

- simple backache - arthritis - strains - bruises - sprains

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

- simple backache - arthritis - strains - bruises - sprains

WARNINGS

Warnings

For external use only

- avoid contact with eyes and mucous membranes
- do not bandage tightly
- do not use with a heating pad
- do not apply to wounds or damaged skin

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or symptoms clear up and occur again.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 do not use, ask a doctor.

Other information store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

INACTIVE INGREDIENT

Inactive Ingredients

purified water, stearic acid, glyceryl stearate, PEG-100 stearate, lanolin, triethanolamine, polysorbate 80, carbomer, disodium EDTA, potassium hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID ULTRA STRENGTH MUSCLE RUB 
menthol, camphor, and methylsalicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
LANOLIN (UNII: 7EV65EAW6H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0406-4	1 in 1 CARTON
1		57 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/28/2011

Labeler - RITE AID CORPORATION (014578892)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture