Label: WINCO FOODS MEDICATED CHEST RUB (camphor- synthetic, eucalyptus oil, and menthol ointment

  • 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 February 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Camphor (synthetic) 4.8%

    Eucalyptus oil 1.2%

    Menthol 2.6%

    Cough suppressant & topical analgesic

    Cough suppressant

    Cough suppressant & topical analgesic

  • Uses

    Temporarily relieves throat and chest

    • cough
    • aching muscles
    • minor aches and pains
  • 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

    • asthma
    • excessive phlegm (mucus)
    • emphysema
    • persistent or chronic cough
    • cough associated with smoking

    When using this product, do not

    • heat
    • microwave
    • use near 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

    • muscle aches and pain persist for more than 7 days or comes back.
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a seriuos condition

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

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    see important warnings above

    • children under 2 years of age, ask a doctor before using this product
    • adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
  • Other information

    • store at room temperature
  • Inactive ingredients

    cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

  • Questions?

    800-824-1706 Monday-Friday 9am-4pm MST

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    WINCO FOODS MEDICATED CHEST RUB 
    camphor (synthetic), eucalyptus oil, and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.048 g  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.012 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.026 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-410-041 in 1 CARTON02/01/2023
    1117 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2023
    Labeler - WinCo Foods, LLC (056098817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(67091-410)
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