Label: XTRACARE VAPORIZING CHEST RUB- camphor, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients                                                 Purpose

    Camphor 4.8% ..................................... Cough Suppressant

    Menthol 1.0% ............................................ Topical Analgesic

  • PURPOSE

    Uses

    • on chest and throat, temporarily relieves cough as may occur with common cold and minor bronchial irritation.
    • for the temporary relief of pain associated with minor skin irritation.
  • 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

    XtraCare® Vaporizing Chest Rub

    Cough Suppressant

    Net Wt 4 Oz (113 g)

  • 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) 
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema

    When using this product, do not

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

    Stop use and ask a doctor if

    • muscle 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 headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use. 

  • DOSAGE & ADMINISTRATION

    Directions

    • see important warnings under "When using this product"
    • adults and children 2 years old and older:
    • rub a thick layer on chest & throat or rub on sore aching muscles
    • cover with a warm, dry cloth if desired
    • keep clothing loose about throat chest to help vapors reach the nose/mouth
    • repeat up to three times per 24 hours or as directed by doctor
    • children under 2 years: do not use
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

  • OTHER SAFETY INFORMATION

    Other Information:store at room temperature

    Questions/Comments?1-855-345-5575

    DISTRIBUTED BY:

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE VAPORIZING CHEST RUB 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g  in 113 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-051-01113 g in 1 BOTTLE; Type 0: Not a Combination Product01/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/30/2014
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-051)