Label: ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION (camphor- synthetic, levomenthol, eucalyptus ointment
- NDC Code(s): 80591-001-01
- Packager: AYUSHREE PHARMACEUTICALS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated July 28, 2021
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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
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
- 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
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
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
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 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80591-001-01 113 g in 1 DRUM; Type 0: Not a Combination Product 09/28/2020 02/28/2024 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 Business Operations AYUSHREE PHARMACEUTICALS PRIVATE LIMITED 861375952 manufacture(80591-001)