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Vitapirena

Dosage form: ointment
Ingredients: CAMPHOR (SYNTHETIC) 4.8g in 100g, EUCALYPTUS OIL 1.2g in 100g, MENTHOL 2.6g in 100g
Labeler: Pharmadel LLC
NDC Code: 55758-018

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.

Active ingredients........................................Purpose

Camphor 4.8%                                                Cough suppressant & topical analgesic

Eucalyptus oil 1.2%                                         Cough suppressant

Menthol 2.6%                                                  Cough Suppressant & topical analgesic

Cough suppressant & topical analgesic

Cough suppressant

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

For external use only; avoid contact wiht eyes.

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.

Do not use

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

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

Stop use and ask doctor if 

  • muscle aches and pains persist 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 serious condition.

If pregnant or breast-feeding, ask a healthprofessional 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"

  • 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 doctor
  • children under 2 years of age: do not use

Other information

  • store at room temperature

Inactive ingredients cederleaf oil, nutmeg oil, special petrolatum, thymol, turpentine oil

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

VITAPIRENA 
camphor, eucalyptus, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL1.2 g  in 100 g
MENTHOL (MENTHOL) MENTHOL2.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL 
NUTMEG OIL 
PETROLATUM 
THYMOL 
TURPENTINE OIL 
Packaging
#Item CodePackage Description
1NDC:55758-018-03100 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - Pharmadel LLC (026095439)

Revised: 01/2015
 
Pharmadel LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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