Otc - Active Ingredient
Active Ingredients Purpose
Menthol 2.6% Cough supressant/Topical Analgesic
Camphor 4.8% Cough supressant/Topical Analgesic
Eucalyptus oil 1.2% Cough Supressant
Medicated Chest Rub Cream
FDA Label NDC 30400-701
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt Ltd. for the product Medicated Chest Rub (NDC 30400-701). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, medicated chest rub, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses Temporarily relieves throat and chest
- cough
- nasal congestion due to common cold
- aching muscles
- minor aches and pains
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Stop use and ask a doctor if
muscle aches/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. Thes could be signs of a serious condition
Warnings
Warnings
For external use only
Do not use
- by mouth
- in nostrils
- on wounds or damaged skin
- with light bandages
Ask a doctor before use if you have
- asthma
- excessive phlegm (mucus)
- emphysema
- persistant or chronic cough
- cough associated with smoking
When using this product do not
- heat
- microwave
- use near open flame
- add to hot water or any container where heating water may cause splattering and result in burns
If pregnant or breat feeding, ask a health professional before use
Dosage & Administration
Directions
- see important warnings under "When Using this product"
- children under 2 years of age, ask a doctor before using the product
- Adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
Inactive Ingredient
Other information Store at room temperature
Inactive ingredients cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Medicated Chest Rub
Label (2.6 03)
* Please review the disclaimer below.
