ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION by AYUSHREE PHARMACEUTICALS PRIVATE LIMITED

ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION by

Drug Labeling and Warnings

ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION by is a Otc medication manufactured, distributed, or labeled by AYUSHREE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION- camphor (synthetic), levomenthol, eucalyptus ointment 
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED

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 Ingredient                        Purpose

Camphor 5.00% ......................... Cough suppressant, nasal decongestant & topical analgesic

Menthol 2.60% .......................... Cough suppressant, nasal decongestant & topical analgesic

Eucalyptus Oil 1.20% .................. Cough suppressant, nasal decongestant & topical analgesic

Use

Temporarily relieves symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

Temporarily relieves minor aches and pains of muscles.

Warnings

For external use only. Avoid contact with eyes.
Ask a doctor before use if you have

  • Cough with excessive phlegm (mucus)
  • Chronic cough that lasts or as occurs with smoking, asthma or emphysema.

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water.

May cause splattering and result in burns.

  • Muscle aches and pains persist for more than 7 days or come back.
  • Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be sign of a serious condition

If pregnant or breast-feeding, consult a physician before use.

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

Directions

See important warnings under "Do not use this product".

  • Children under 2 years of age, ask a doctor.
  • Adults and children 2 years of age or older: Rub a thick layer on chest and throat. If desired. loosely cover with a soft dry cloth but keep clothing loose.
  • Repeat up to 3 times daily, or as directed by a doctor.

Inactive ingredients

BHT, Cedar Oil, Hard Wax, Light Liquid Paraffin, Micro Wax, Nutmeg Oil, Pine Oil, Thymol.

Package Label - Principal Display Panel

Label

ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION 
camphor (synthetic), levomenthol, eucalyptus ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80591-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL2.6 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
PARAFFIN (UNII: I9O0E3H2ZE)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
NUTMEG OIL (UNII: Z1CLM48948)  
WHITE PINE OIL (UNII: HA5CX6676U)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80591-001-01113 g in 1 DRUM; Type 0: Not a Combination Product09/28/202002/28/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/28/202002/28/2024
Labeler - AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (861375952)
Establishment
NameAddressID/FEIBusiness Operations
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED861375952manufacture(80591-001)

Revised: 7/2021
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.