Label: PHARMACYS PRESCRIPTION- vapor rub gel

  • 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 June 2, 2014

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    MENTHOL 1%

    CAMPHOR 4.7%

  • PURPOSE

    To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.

  • PURPOSE

    DECONGESTANT AND COUGH SUPPRESSANT

  • Warnings

    For external use only. Avoid contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin. If pregnant or breastfeeding, consult a physician before use. Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.

  • PRINCIPAL DISPLAY PANEL

    label

  • Consult a physician before use

    If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days, comes back or occurs with fever, rash or a persistent headache.

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

    Directions

    Adults and children 2 years of age and older rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. If desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.

    Inactive ingredients

    Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION 
    vapor rub gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 50 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-018-04110 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/2014
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD530766098manufacture(76176-018)
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