Label: CHEST RUB VAPORIZING ACTION- menthol and camphor and eucalyptus oil gel

  • 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 21, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor            4.8%

    Menthol              2.6%

    Eucalyptus Oil    1.2%

  • PURPOSE

    Purpose

    Cough Suppressant

    Nasal Decongestant

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily releives symptoms associated with the common cold:

    • cough
    • nasal congestion
    • chest congestion

    Temporarily relives minor aches and pains of muscles.

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

  • ASK DOCTOR

    Ask a doctor before use if you have,

    • chronic cough that lasts or as occurs with smoking, asthma, or emphysema
    • cough with excessive phlegm (mucus)
  • DO NOT USE

    Do not use this product

    • near an open flame
    • by adding water
    • by mouth
    • in a microwave oven
    • on wounds or damaged skin
    • with tight bandages
    • in nostrils
    • added to hot water or any container where you are heating water
    • may cause splattering and results in burns
  • STOP USE

    Stop use and ask a doctor if:

    • if muscle aches and pains persist for more than 7 days or come back
    • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions
    • if pregnant or breast-feeding, consult a physician before use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions: see important warnings under “Do not use this product”

    children under 2 years of age, ask a doctor

    adults and children 2 years  of age or older:

    • rub a thick layer on chest and throat
    • if desired, loosely cover with a soft dry cloth but keep clothing loose
    • repeat up to 3 times daily, or as directed by a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Parrafin.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    CHEST RUB VAPORIZING ACTION GEL

    NASAL DECONGESTANT AND COUGH SUPPRESSANT

    NET WT. 4 OZ (113g)

    label

  • INGREDIENTS AND APPEARANCE
    CHEST RUB  VAPORIZING ACTION
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    THYMOL (UNII: 3J50XA376E)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52920-133-48113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/10/2015
    Labeler - Singhfam Corporation (019499958)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52920-133)
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