VAPOR PLUS- camphor, eucalyptus, menthol ointment 
Pharmadel LLC

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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Vapor Plus

Active ingredients
Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Cough suppressant & topical analgesic

Uses

  •  on chest and throat, temporarily relieves cough due to common cold
  • on muscles and joints, temporarily relieves minor aches and pains

Warnings

For extrernal use only; avoid contact with eyes.

Do not use

  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin

Ask a doctor before use if you have

  • a 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 hot water or anycontainer where heating water, may cause splattering and result in burns.

Stop use and ask doctor if

  • muscle aches and pains persists more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of accidental ingestion, 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:
  • rub a thick layer on chest & 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: do not use

Other information

  • store at room temperature

Inactive ingredients:

cedarleaf oil, nutmeg oil, special petrolatum, thymol, turpentine oil.

Questions? call 1-866-359-3478 M-F 9 AM to 4 PM EST

Vapor Plus Label

VAPOR PLUS 
camphor, eucalyptus, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
NUTMEG OIL (UNII: Z1CLM48948)  
PETROLATUM (UNII: 4T6H12BN9U)  
THYMOL (UNII: 3J50XA376E)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-101-041 in 1 CARTON02/21/201201/01/2017
1100 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/21/201201/01/2017
Labeler - Pharmadel LLC (026095439)

Revised: 1/2017
 
Pharmadel LLC