Otc - Active Ingredient
Active ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.6%
Medicated Chest Rub Ointment
FDA Label NDC 55910-833
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. for the product Medicated Chest Rub (NDC 55910-833). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cough suppressant & topical analgesic
Cough suppressant
Cough suppressant & topical analgesic
Indications & Usage
Uses
• when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
• when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Warnings
Warnings
For external use only;avoid contact with eyes.
Otc - Do Not Use
Do not use
• by mouth
• in nostrils
• on wounds or damaged skin
• with tight bandages
Otc - Ask Doctor
Ask a doctor before use if you have
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
Otc - When Using
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.
Otc - Stop Use
Stop use and ask a doctor if
• muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
see important warnings under "When using this product"
adults and children 2 years and over:
- for cough suppression
- rub a thick layer on throat & chest
- cover with a warm, dry cloth if desired
- keep clothing loose about throat and chest to help vapors reach the nose and mouth
- use up to three times daily or as directed by doctor
- for muscle/joint minor aches and pains apply to affected area not more than 3 to 4 times daily
children under 2 years: do not use
Other Safety Information
Other information
• store at room temperature
Inactive Ingredient
Inactive ingredientscedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil
Otc - Questions
Questions or comments?
Call 1-866-4-REXALL
Package Label.Principal Display Panel
Dg-rexall-100g-label (Dg Rexall 100g Label)
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