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 58037-110
8 label sections · Submitted to the FDA by New Pride Corp · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New Pride Corp for the product Medicated Chest Rub (NDC 58037-110). 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
when applied to chest or throat, temporarily relieves cough due to minor throat and bronchial irritation associated with a common cold. When applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints.
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.
Ask a doctor before use if you have: cough that occurs with too much phlegm (mucus); chronic cough persists 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); take by mouth or place in nostrils; use in or near eyes; apply to wounds or damaged skin; bandage tightly; use with other topical pain relievers.
Stop use and ask a doctor if: muscle aches and pains worsen and persist more than 7 days or clear up and occur again within a few days; cough persists more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache; redness or irritation develops.
If pregnant or breast feeding: ask a health professional before use.
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions (see warnings under "when using this product"): For cough suppression - adults and children 2 years and older: rub on throat and chest in a thick layer; clothing should be loose around throat and chest to help vapors reach the nose and mouth; use up to 3 times daily or as directed by a doctor; children under 2 years of age: ask a doctor. For muscle and joint minor aches and pains - adults and children 2 years and older: clean affected area before applying; apply not more than 3 to 4 times daily; children under 2 years of age: consult a doctor.
Inactive Ingredient
Other information Store at room temperature
Inactive ingredients cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Medicated Chest Rub
label
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