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Rite Aid Ultra Strength Muscle Rub

Dosage form: ointment
Ingredients: MENTHOL 100mg in 1g, CAMPHOR (SYNTHETIC) 40mg in 1g, METHYL SALICYLATE 300mg in 1g
Labeler: RITE AID CORPORATION
NDC Code: 11822-0406

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredient                                 Purpose

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





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. If swallowed, get medical help or contact a
Poison Control Center right away.
Uses

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

- simple backache - arthritis - strains - bruises - sprains

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.


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 Ingredients

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




RITE AID ULTRA STRENGTH MUSCLE RUB 
menthol, camphor, and methylsalicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0406
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)40 mg  in 1 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER HOMOPOLYMER TYPE C 
GLYCERYL MONOSTEARATE 
EDETATE DISODIUM 
TROLAMINE 
LANOLIN 
POTASSIUM HYDROXIDE 
POLYSORBATE 80 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:11822-0406-41 TUBE (TUBE) in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/28/2011
Labeler - RITE AID CORPORATION (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 03/2011
Document Id: 7dfafb22-9a79-4cbb-ad09-266755325927
Set id: c679f704-8939-42d2-8401-208c99548281
Version: 1
Effective Time: 20110328
 
RITE AID CORPORATION

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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