VAPORIZING CHEST RUB COUGH SUPRESSANT- camphor (synthetic), eucalyptus oil, and menthol ointment 
Filo America

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.

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VAPORIZING
CHEST RUB

Drug Facts

Active ingredientsPurpose
Camphor 4.7%Cough suppressant/topical analgesic
Eucalyptus oil 1%Cough suppressant
Menthol, natural 1%Cough suppressant / topical analgesic

Use

when applied to chest and throat

when applied to muscles and joints

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

Stop use and ask a doctor if

  • 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.
  • muscle aches and pains worsen, persist for more than 7 days, or clear up occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

for cough suppression

for muscle/joint minor aches and pains apply

other information

if pregnant or breast feeding

Inactive ingredients

Cedar leaf oil, methylparaben, Nutmeg oil, petrolatum, Turpentine oil, Thymol, propylparaben

PRINCIPAL DISPLAY PANEL - 100g Jar Label

VAPORIZING
CHEST RUB

4 oz (113g)

Principal Display Panel - 100g Jar Label
VAPORIZING CHEST RUB  COUGH SUPRESSANT
camphor (synthetic), eucalyptus oil, and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 Oil1 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-502-01113 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/05/2015
Labeler - Filo America (943873703)
Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-502)

Revised: 5/2015
Document Id: 025033fb-5b58-4edd-a7e7-882ffc2a2880
Set id: c34324da-9ee5-4fe9-be04-ef8a67218f2a
Version: 1
Effective Time: 20150505
 
Filo America