VAPORX BALM- camphor, eucalyptus oil, menthol ointment 
Geritrex LLC

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.

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Vaporx Balm

Active Ingredients:

Camphor 4.8%
Eucalyptus Oil 1.2%
Menthol 2.6%

Purpose:

Camphor - Cough Suppressant and Topical Analgesic
Eucalyptus Oil- Cough Suppressant
Menthol- Cough Suppressant and Topical Analgesic 

Uses:

- On chest and throat, temporarily relieves cough due to common cold

- On muscles and joints, temporarily relieves minor aches and pains

Warnings:

For external use only; avoid contact with eyes

Do not use: - by mouth - with tight bandages
- in nostrils - damaged skin or open wounds

Ask your doctor before use if you have:

- Persistent or chronic cough such as occurs with smoking, asthma or emphysema. - If excessive mucous present

When using this product, do not:

- heat - microwave - add to hot water or any container with heating water.
May cause splattering and result in burns 

Stop use and ask doctor if:

- muscle aches and pains persists more than 7 days
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children, if swallowed, get medical help or contact a Poison Control center right away 

Directions:

- Adults and children 2 years and over
- Rub a thick layer on chest & throat or rub on sore aching muscles
- Cover with warm, dry cloth if desired.
- Keep clothing loose around throat/chest to help vapors reach the nose and mouth
- repeat up to three times per 24 hours or as directed by doctor 

Other Information: Store at room temperature

Inactive Ingredients:

nutmeg oil, modified petrolatum, thymol, turpentine oil

Questions? 1-800-736-3437

Vaporx Balm

VAPORX BALM 
camphor, eucalyptus oil, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.4 g  in 50 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.6 g  in 50 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
NUTMEG OIL (UNII: Z1CLM48948)  
PETROLATUM (UNII: 4T6H12BN9U)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-450-5050 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-450)

Revised: 12/2015
Document Id: bdbc592f-23ef-4143-ab06-f257f2952cfa
Set id: 093ed58c-0813-4c56-acd7-e6ac35d44449
Version: 1
Effective Time: 20151230
 
Geritrex LLC