ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION by AYUSHREE PHARMACEUTICALS PRIVATE LIMITED

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80591-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 g in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	2.6 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 80591-001-01	113 g in 1 DRUM; Type 0: Not a Combination Product	09/28/2020	02/28/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/28/2020	02/28/2024

Labeler - AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (861375952)

Name	Address	ID/FEI	Business Operations
Establishment
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED		861375952	manufacture(80591-001)

Revised: 7/2021

Document Id: c8369a0e-932e-8f25-e053-2995a90af213

Set id: 371ce5b3-137c-4287-bc2c-6114ed99a69c

Version: 3

Effective Time: 20210728