Label: VAPORIZING CHEST RUB COUGH SUPRESSANT (camphor- synthetic, eucalyptus oil, and menthol ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-502-01 - Packager: Filo America
- 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 May 5, 2015
If you are a consumer or patient please visit this version.
- 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; avoid contact with eyes.
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
- 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
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Directions
- see important warnings under "When using this product"
- adults and children 2 year and over.
for cough suppression
- rub a thick layer on the throat and 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 3 times daily, or as directed by a doctor
for muscle/joint minor aches and pains apply
- to affected area not more than 3-4 times daily
- children under 2 yeas : ask a doctor
other information
- store at room temperature
if pregnant or breast feeding
- ask a health professional before use
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 100g Jar Label
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INGREDIENTS AND APPEARANCE
VAPORIZING CHEST RUB COUGH SUPRESSANT
camphor (synthetic), eucalyptus oil, and menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-502 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 4.7 g in 100 g Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662) Eucalyptus Oil 1 g in 100 g Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 1 g in 100 g Inactive Ingredients Ingredient Name Strength Nutmeg Oil (UNII: Z1CLM48948) 0.6 g in 100 g TURPENTINE OIL (UNII: C5H0QJ6V7F) Petrolatum (UNII: 4T6H12BN9U) propylparaben (UNII: Z8IX2SC1OH) THYMOL (UNII: 3J50XA376E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-502-01 113 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/05/2015 Labeler - Filo America (943873703) Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-502)
