Label: SWEET COMFORT- menthol oil

  • NDC Code(s): 69204-004-04, 69204-004-05
  • 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 relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.  Supresses your 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.

  • 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).
    • epilepsy
  • 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.
    • sun tan/use tanning beds for 3-4 days after use.
  • 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

    Benzoin, lavender oil, lemon oil, melaleuca alternifolia (tea tree) leaf oil, olibanum, pine needle oil, and prunus armeniaca (apricot) kernel oil. 

  • Questions?

    1-877-275-7253

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

  • SPL UNCLASSIFIED SECTION

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

  • Sweet Comfort 10 ml

    SKU 431701

  • Sweet Comfort 6 ml

    Lift Here

    SKU 432301

  • DISPOSAL AND WASTE HANDLING

    We support recycling. Please recycle where possible.

  • Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub - 10 ml

    sweet comfort

    Saje® Natural Wellness

    Sweet Comfort

    Antitussive (Cough Suppressant) Oil Blend Rub

    For external use only.

    0.34 fl. oz. | 10 ml


    Sweet Comfort Box 10 ml

  • Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub - 6 ml

    sweet comfort

    Saje® Natural Wellness

    Sweet Comfort

    Antitussive (Cough Suppressant) Oil Blend Rub

    For external use only.

    0.2 fl. oz. | 6 ml

    Sweet Comfort Box 10 ml

  • INGREDIENTS AND APPEARANCE
    SWEET COMFORT 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24.56 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEMON OIL (UNII: I9GRO824LL)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeFREEFORM (oil) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69204-004-041 in 1 BOX10/16/2016
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69204-004-051 in 1 BOX10/16/2016
    26 mL in 1 BOTTLE, DROPPER; 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(69204-004)
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