OTC Medication Information: ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION

ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION- camphor (synthetic), levomenthol and eucalyptus oil 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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 5 g in 100 g
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 2.6 g in 100 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 1.2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CEDAR LEAF OIL
PARAFFIN
LIGHT MINERAL OIL
MICROCRYSTALLINE WAX
NUTMEG OIL
WHITE PINE OIL
THYMOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80591-001-01 113 g in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/28/2020 02/28/2024
Labeler — AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (861375952)
Establishment
Name Address ID/FEI Operations
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED 861375952 manufacture (80591-001)

Revised: 07/2021 AYUSHREE PHARMACEUTICALS PRIVATE LIMITED

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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