Label: AMAR VAPORIZING CHEST RUB (camphor- synthetic, eucalyptus oil, and menthol ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 41499-122-01 - Packager: Amar Remedies Limited - Mumbai
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 29, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
For external use only
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts or as occurs with smoking, asthma, or emphysema
When using this product
- do not heat
- do not microwave
- do not add to hot water or any container where heating water. May cause splattering and result in burns.
- do not take by mouth or place in nostrils
- do not get into eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
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Directions
- see important warnings under "When using this product"
- adults and children 2 year and over.
- rub a thick layer on the throat and chest cough, or rub on sore aching muscles or joints
- cover with a warm, dry cloth if desired
- clothing should be left loose about the 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 yeas : ask a doctor
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 100g Jar Label
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INGREDIENTS AND APPEARANCE
AMAR VAPORIZING CHEST RUB
camphor (synthetic), eucalyptus oil, and menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41499-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 5.25 g in 100 g Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662) Eucalyptus Oil 1.6 g in 100 g Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 3.15 g in 100 g Inactive Ingredients Ingredient Name Strength Nutmeg Oil (UNII: Z1CLM48948) 0.6 g in 100 g Turpentine (UNII: XJ6RUH0O4G) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41499-122-01 100 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2010 Labeler - Amar Remedies Limited - Mumbai (677141751)