VAPORIZING CHEST RUB (MENTHOL AND CAMPHOR AND EUCALYPTUS OIL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]

VAPORIZING CHEST RUB (MENTHOL AND CAMPHOR AND EUCALYPTUS OIL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-012-08, 52000-012-09, 52000-012-10, 52000-012-11, 52000-012-12, 52000-012-13, 52000-012-14
Set ID d1b1c91e-d101-48bd-b4e0-ed8b3706f990
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • 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
    2NDC:52000-012-0956.6 g in 1 BOTTLE, PLASTIC
    3NDC:52000-012-10100 g in 1 BOTTLE, PLASTIC
    4NDC:52000-012-11113 g in 1 BOTTLE, PLASTIC
    5NDC:52000-012-12150 g in 1 BOTTLE, PLASTIC
    6NDC:52000-012-13170 g in 1 BOTTLE, PLASTIC
    7NDC:52000-012-14226 g in 1 BOTTLE, PLASTIC
    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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