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Cold Rub

Dosage form: ointment
Ingredients: CAMPHOR (NATURAL) 4.8g in 100g, EUCALYPTUS OIL 1.2g in 100g, MENTHOL 2.8g in 100g
Labeler: JMD All Star Impex Inc.
NDC Code: 51444-001

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.

Active Ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.8%

PURPOSE

cough suppressant/topical analgesic
nasal decongestant/cough suppressant
cough suppressant/topical analgesic

Uses

Temporarily relief for throat and chest

  • Cough 
  • Nasal congestion due to common cold
  • Aching muscles
  • Minor aches and pains

Warning
For external use only. Avoid contact with eyes.

Do not use
  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with light bandages

Ask a doctor before use if you have

  • Asthma
  • Excessive phlegm (mucus)
  • Emphysema
  • Persistent or chronic cough
  • Cough associated with smoking

If pregnant or breast feeding, ask a health professional before use

Keep out of reach of children. If case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • See important warnings under "When using product"
  • Children under 2 years of age, ask a doctor before using the product
  • Adults and children 2 years of age and older: rub a thick layer chest and throat or sore aching muscles. If desired loosely cover with a soft cloth but keep clothing loose. Repeat up to 3 times daily

Other Information
  • Store at room temperature

Other Ingredients
Cedar leaf Oil, Mineral Oil, Nutmeg Oil, Petrolatum, Spirits of Turpentine, Thymol

Package Label

COLD RUB 
camphor eucalyptus oil menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51444-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)4.8 g  in 100 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL1.2 g  in 100 g
MENTHOL (MENTHOL) MENTHOL2.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL 
NUTMEG 
PETROLATUM 
THYMOL 
TURPENTINE 
Packaging
#Item CodePackage Description
1NDC:51444-001-38108 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2010
Labeler - JMD All Star Impex Inc. (962316662)
Establishment
NameAddressID/FEIOperations
Steller Mercantile Pvt.Ltd.650493005manufacture

Revised: 05/2010
Document Id: e9885138-6619-4675-83a7-eedadeeca8a8
Set id: 7f07d3cb-6075-475a-a7ab-62216933f6b5
Version: 1
Effective Time: 20100530
 
JMD All Star Impex 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 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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