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

  • NDC Code(s): 30400-702-01, 30400-702-02, 30400-702-03
  • Packager: Jell Pharmaceuticals Pvt Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 15, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor            4.7%

    Menthol             1.0%

    Eucalyptus Oil   1.0%

  • PURPOSE

    Purpose

    Cough Suppressant

    Topical Analgesic

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation.
    • For the temporary relief of pain associated with minor skin irritation.

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

    Do not take by mouth or place in nostrils.

  • DO NOT USE

    Do not use

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

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

  • ASK DOCTOR

    Ask doctor if you have,

    • cough that occurs with too much phlegm (mucus)
  • WHEN USING

    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

    Stop use and ask a doctor if:

    • cough  that lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    If ingested get medical help or contact a Poison control center immediately

  • DOSAGE & ADMINISTRATION

    Directions: see important warnings under “When using this product”

    adults and children 2 years and over:

    • rub a thick layer on chest and throat
    • keep clothing loose around chest/throat to help vapors reach the nose/mouth
    • use up to 3 times daily as directed by doctor

    children under 2 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Petrolatum, Mineral Oil,  Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART VAPORISING CHEST RUB GEL

    DECONGESTANT AND COUGH SUPPRESSANT

    NET WT.4 OZ (113g)

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-702
    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
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-702-0150 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    2NDC:30400-702-0256.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    3NDC:30400-702-03100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2022
    Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(30400-702)
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