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Omega Pain Relieving

Dosage form: liniment
Ingredients: CAMPHOR (SYNTHETIC) 4mL in 100mL, MENTHOL 3.331 in 100mL, METHYL SALICYLATE 14.775mL in 100mL
Labeler: International Pharmaceuticals, Inc.
NDC Code: 58929-200

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.

Omega Pain Relieving Liniment

Active Ingredients                                                               Purpose

Camphor 4.0 percent

                                           ............................................Topical Analgesic

Menthol 3.33 percent

Methyl Salicylate 14.775 percent .....................................Counterirritant

Uses

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

Simple Backache

Arthritis

Strains


Warnings

For external use only.           Avoid Contact with eyes.

If condition worsens, or if symptoms persist for more than

7 days or clear up and occur again within a few days,

discontinue use of this product and consult a doctor.

When used for arthritis, if pain persists for more than 10 days,

or redness is present, or in conditions affecting children under

12 years of age, consult a physician immediately.

Do Not

use otherwise than as directed.

apply to wounds or damaged skin.

bandage tightly.


Stop use and ask a doctor if

redness is present.

excessive irritation of the skin develops.



Keep out of reach of children.

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

Directions

Shake well before using.

Adults and children 3 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 3 years of age: Consult a physician.


Other information

Store at 20 to 30 celsius  (68 to 86 Fahrenheit)


Inactive Ingredients

Carboxymethylcellulose Sodium,
D and C Green number 6, D and C Yellow number 11, Eucalyptus Oil, Light Mineral Oil, Magnesium, Aluminum Silicate,
Methylparaben, Oleic Acid, Propylparaben, Purified Water, Sodium Octoxynol-2 Ethane Sulfonate, Sorbitol Solution, Triethanolamine,
Turpentine Oil.

Omega Pain Relieving Liniment

For external use only.

Net 4 fl oz (120 ml)

For your protection, this bottle is provided with a pilfer proof cap imprinted with the IPI

logo in red. Do not use if cap has been tampered with or is broken or destroyed.






Manufactured By

International Pharmaceuticals, Inc.

Juan Luna Avenue, Mabolo,

Cebu City 6000 Philippines

Product Of The Philippines

Shake well before using

www.ipi-phil.com


OMEGA PAIN RELIEVING 
camphor, menthol, methyl salicylate liniment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58929-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)4 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL3.33   in 100 mL
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE14.775 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
D&C GREEN NO. 6 
D&C YELLOW NO. 11 
EUCALYPTUS OIL 
LIGHT MINERAL OIL 
MAGNESIUM 
ALUMINUM SILICATE 
METHYLPARABEN 
OLEIC ACID 
PROPYLPARABEN 
WATER 
SORBITOL 
TROLAMINE 
TURPENTINE 
Packaging
#Item CodePackage Description
1NDC:58929-200-001 BOTTLE (BOTTLE) in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34805/24/2010
Labeler - International Pharmaceuticals, Inc. (718692460)
Registrant - International Pharmaceuticals, Inc. (718692460)
Establishment
NameAddressID/FEIOperations
International Pharmaceuticals, Inc.718692460manufacture

Revised: 05/2010
 
International Pharmaceuticals, Inc.

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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