Otc - Active Ingredient
Active Ingredients Purpose
Camphor 4.8 % Cough Suppresant & Topical Analgesic
Eucalyptus Oil 1.2% Cough Suppresant
Menthol 2.6% Cough Suppresant and Topical Analgesic
The following Structured Product Label (SPL) was submitted to the FDA by Prosana Distribuciones, S.a. De C.v. for the product Vapour Rub (NDC 69728-0020). 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, uses, store, inactive ingredients, directions-see important warnings under "when using this product", for external use only, ask a doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
Camphor 4.8 % Cough Suppresant & Topical Analgesic
Eucalyptus Oil 1.2% Cough Suppresant
Menthol 2.6% Cough Suppresant and Topical Analgesic
-on 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
Other Information-Store at room temperature
Inactive ingredients
cedarleaf oil, nutmeg oil, spirits of turpentine, thymol
Directions-See important warnings under "When Using This Product"
For external use only; avoid contact with eyes
Do not use
-by mouth
-in nostrils
-on wounds
or damaged skin
-with light bandages
Ask a doctor before use if you have
-cough that occurs with too much phlegm
-persistant 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 and result in burns.
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 after a few days
-cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent cough may be a sign of a serious condition
If pregnant or breastfeeding ask a health professional before use
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.
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 and chest
-cover with a warm cloth if desired
-keep clothing loose around throat and chest to help vapors reach the nose and mucus
-use up to three times a day or as directed by a doctor
-for muscle/joint aches and pains apply to affected area no more than 3 to 4 times daily
-children under 2 years do not use
Keep out of reach of children. If swallowed, get medical help or contact a Poison Center
Failure to follow these warnings could result in serious consequences
For external use only, avoid contact with eyes
Do not use-by mouth-in nostrils-on wounds of damaged skin-with tight bandages
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 and result in burns
Stop use and ask a doctor if
-musche aches and pains worsen or persist for more than 7 days or clear up and accur again after a few days
-cough persit for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent cough may be a sign of a serious condition
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