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

  • NDC Code(s): 52862-016-01, 52862-016-14, 52862-016-19, 52862-016-20, view more
    52862-016-21, 52862-016-31, 52862-016-32
  • Packager: Home Smart Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2024

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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

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-016
    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:52862-016-1950 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    2NDC:52862-016-3156.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    3NDC:52862-016-20100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    4NDC:52862-016-14113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    5NDC:52862-016-32150 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    6NDC:52862-016-21170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    7NDC:52862-016-01226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2013
    Labeler - Home Smart Products (161872676)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-016)
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