The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Camphor, Eucalyptus Oil And Menthol (NDC 59779-717). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient PurposeCamphor 5.2%.............................Cough Suppressant and topical analgesicEucalyptus oil 1.2%......................Cough SuppressantMenthol2.8%................................Cough Suppressant and topical analgesic
Otc - Purpose
Active ingredient PurposeCamphor 5.2%.............................Cough Suppressant and topical analgesicEucalyptus oil 1.2%......................Cough SuppressantMenthol2.8%................................Cough Suppressant and topical analgesicUses - on chest and throat, temporarily relieves cough due to common cold- On muscles and joints, temporarily relieves minor aches and pains
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Uses - temporarily relieves cough due to minor throatand bronchial irritation associated with a cold.
Warnings
Warnings For external use only; avoid contact with the eyes.Do not use- by mouth - with tight bandages - in nostrils - on wounds or damaged skin 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.When using this product, do not- heat - microwave - add to hot water or any container where heating water.May cause splattering andresult in burns.Stop use and ask a doctor if-muscle aches and pains persist for more than 7 days or come back- cough lasts for more than 7 days, comes back or occurs with fever, rash orpersistent headache. These could be signs of a serious condition.If pregnant or breast feeding, ask a professional before use. Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Center right away.
Dosage & Administration
Directions- See Important warnings under "When using this product"- Adults and children 2 years and older:- rub a thick layer on chest and throat or rub on sore aching muscles- cover with a warm, dry cloth if desired- keep clothing loose about throat/chest to help vapors reach the nose/mouth- repeat up to three times per 24 hours or as directed by a doctor.Children under 2 years of age" ask a doctor.Other Informationstore at room temperature
Inactive Ingredient
Inactive IngredientsCarbomer 954, cedarleaf oil, cetyl alcohol,cetyl palmitate, cyclomethicone copolyol,dimethicone copolyol, dimethicone, ETDA, glycerin, imidazolidinyl urea, isopropyl palmitate,methylparaben, nutmeg oil, PEG-100 stearate,propylparaben, purified water, sodium hydroxide,stearic acid, thymol, titanium dioxide,turpentine oil
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