VAPORIZING CHEST RUB 4 OZ. (CAMPHOR, EUCALYPTUS OIL, MENTHOL) OINTMENT [REJOICE INTERNATIONAL INC.]

VAPORIZING CHEST RUB 4 OZ. (CAMPHOR, EUCALYPTUS OIL, MENTHOL) OINTMENT [REJOICE INTERNATIONAL INC.]
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NDC 57337-097-01
Set ID 7173b141-123e-6cd4-e053-2a95a90a8600
Category HUMAN OTC DRUG LABEL
Packager Rejoice International Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients

    Camphor, 4.8%

    Eucalyptus Oil, 1.2%

    Menthol, 2.6%

  • PURPOSE

    Purpose

    Cough suppressant & topical analgesic

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.
    • temporarily relieves minor aches and pains of muscles and joints
  • WARNINGS

    Warnings

    For external use only; avoid contact with eyes

    Do not use

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

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough such as occurs with persistent of chronic smoking, asthma or emphysema

    When using this product, do not

    • heat
    • microwave
    • add to hot water or any container where heating water. May cause spattering and result in burns.

    Stop use and ask a doctor if

    • muscles 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 headche. These could be signs of a serious condition.
  • DOSAGE & ADMINISTRATION

    Directions

    • See important warnings under "When using this product"
    • adults and children 2 years and older

    For cough suppression

    • rub a thick layer on chest & throat
    • cover with a warm, dry cloth if desired
    • keep clothing loose and throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily or as directed as doctor
    • for muscle / joint minor aches and pains apply to affected areas not more than 3 to 4 times daily
    • children under 2 years; do not use
  • INACTIVE INGREDIENT

    Inactive ingredients

    Cedarleaf Oil, Nutmeg Oil, Petrolatum, Thymol, Turpentine Oil

  • PRINCIPAL DISPLAY PANEL

    label

    image

  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 4 OZ. 
    camphor, eucalyptus oil, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4.8 g  in 100 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-097-011 in 1 BOX07/20/2018
    1113 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/20/2018
    Labeler - Rejoice International Inc. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Technology Co., Ltd.529287434manufacture(57337-097)

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