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Drug Facts
Theracare Medicated Chest Rub Ointment
FDA Label NDC 71101-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Medicated Chest Rub (NDC 71101-200). 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 other, active ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, do not, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.6%
Purpose
Camphor 4.8% Cough suppressant, topical analgesic
Menthol 2.6% Cough suppressant, topical analgesic
Eucalyptus oil 1.2% Cough suppressant
Uses
- Temporarily relieves throat and chest
- cough
- nasal congestion due to common cold
- aching muscles
- minor aches and pains
Warnings
For external use only; avoid contact with eyes.
Do Not Use
- by mouth
- in nostrils
- on wounds or damaged skin
- with tight bandages
Ask A Doctor Before Use If You Have
- asthma
- excessive phlegm (mucus)
- emphysema
- persistent 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
Stop Use And Ask A Doctor If
- muscle aches/pain persist more than 7 days or comes back
- cough lasts more than 7 days or comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.
Directions
see important warnings under " When using this product"
- children under 2 years of age, ask a doctor before using this product
- rub a thick layer on chest & fractor rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
adults and children 2 years and over:
Other Information
- store at room temperature
Inactive Ingredients
cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
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