Label: NUVALU VAPORIZING CHEST RUB- camphor, eucalyptus oil, menthol gel

  • NDC Code(s): 76176-221-24
  • Packager: Ningbo Liyuan Daily Chemical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 1, 2018

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  • Active Ingredients

    Camphor, 4.7 percent

    Eucalyptus Oil, 1 percent

    Menthol, 1 percent

  • Purpose

    Cough Suppressant and Topical Analgesic

    Cough Suppressant

    Cough Suppressant and Topical Analgesic

  • USES

    on chest and throat, to temporarily relieve cough

    use on aching muscles to temporarily relieve minor aches

  • WARNINGS:

    For external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven.

  • Consult a doctor and discontinue use;

    If cough persists for more than 1 week, tends to recur or is accompanied by fever, rash, or persistant headache.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • DIRECTIONS:

    Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapors rise to nose and mouth. Repeat up to three times daily, especially at bed time, or as directed by a doctor. Children under two years of age, consult a doctor.

  • Inactive ingredients:

    petrolatum, mineral oil, nutmeg, spirits of turpentine, cedarleaf oil, thymol.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NUVALU VAPORIZING CHEST RUB 
    camphor, eucalyptus oil, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.7 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NUTMEG OIL (UNII: Z1CLM48948)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    THYMOL (UNII: 3J50XA376E)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-221-24113 g in 1 JAR; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2018
    Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(76176-221)
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