Label: CHEST COMFORT- menthol salve

  • NDC Code(s): 69204-002-01
  • Packager: Natures Formulae Health Products Ltd.
  • 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 October 16, 2016

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  • SPL UNCLASSIFIED SECTION

    IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

  • DRUG FACTS Active ingredient

    Menthol 2.76%

  • PURPOSE

    Purpose Antitussive (Cough Suppressant)

    Uses Temporarily suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.  Controls the impulse to cough to help you get to sleep.

  • Warnings

    For external use only.

    Do not take by mouth or place in nostrils

    Flammable: Keep away from fire or flame.

  • Do not use

    • if epileptic
    • with high blood pressure
  • Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
  • When using this product, do not

    • heat
    • microwave
    • use near an open flame
    • add to hot water or any container where heating water.  May cause splattering and result in burns.
  • 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 headache.  A persistent cough may be a sign of a serious condition. 

  • If pregnant or breast-feeding,

    do not use this product.

  • Keep out of reach of children. 

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • See important warnings under 'When using this product'.
    • Adults and children 12 years of age and older: rub on the throat and chest in a thick layer
    • cover with a warm, dry cloth if desired
    • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • DOSAGE & ADMINISTRATION

    • use up to three times daily or as directed by a doctor.
    • Children under 12 years of age: ask a doctor. 
  • Other information

    • Close container tightly and store at room temperature away from heat.
  • Inactive ingredients

    Beeswax (yellow), melaleuca alternifolia (tea tree) leaf oil, olibanum, peppermint oil, piper nigrum (pepper) seed oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

  • Questions?

    1-877-275-7253

  • SPL UNCLASSIFIED SECTION

    Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada 

    SKU 435601

    Do not use if security seal around bottle is broken or missing.

    Lift Here

  • DISPOSAL AND WASTE HANDLING

    We support recycling. Please recycle where possible.

  • Chest Comfort Antitussive (Cough Suppressant) Balm

    Saje® Natural Wellness

    Chest Comfort

    Antitussive (Cough Suppressant) Balm

    net wt. 1.91 oz | 54.1 g

    Chest Comfort 54.1 g BOX

  • INGREDIENTS AND APPEARANCE
    CHEST COMFORT 
    menthol salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL27.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69204-002-011 in 1 BOX10/16/2016
    154.1 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/16/2016
    Labeler - Natures Formulae Health Products Ltd. (241385587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(69204-002)
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