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

  • NDC Code(s): 52000-012-08, 52000-012-09, 52000-012-10, 52000-012-11, view more
    52000-012-12, 52000-012-13, 52000-012-14
  • Packager: Universal Distribution Center LLC
  • 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 November 22, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor            4.7%

    Menthol             1.0%

    Eucalyptus Oil   1.0%

  • PURPOSE

    Purpose

    Decongestant

  • INDICATIONS & USAGE

    Uses

    • on chest and throat, helps temporarily relive cough due to common cold.
    • on joints and muscles, temporarily relives minor aches and pains.
  • WARNINGS

    Warnings

    For external use only; avoid contact with eyes.

  • DO NOT USE

    Do not use

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

    Ask doctor before use if you have,

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma, emphysema, or smoking
  • WHEN USING

    When using this product, do not

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

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
    • muscle aches or pain persist more than 7 days or come back
  • 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

    • adults and children 2 years and over
    • rub a thick layer on chest and throat or rub on sore aching muscles

    • keep clothing loose around chest/throat to help vapors reach the nose/mouth

    • repeat up to 3 times per 24 hours or as directed by doctor
    • do not use on children under 2 years unless directed by doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    VAPORISING CHEST RUB
    NASAL DECONGESTANT AND COUGH SUPPRESSANT
    NET WT.4 OZ (113g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-012
    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:52000-012-0850 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    2NDC:52000-012-0956.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    3NDC:52000-012-10100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    4NDC:52000-012-11113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    5NDC:52000-012-12150 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    6NDC:52000-012-13170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2022
    7NDC:52000-012-14226 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 finalpart34103/15/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-012)
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