Label: ASSURED VAPORIZING CHEST RUB- camphor and eucalyptus oil and menthol ointment

  • NDC Code(s): 33992-7991-4
  • Packager: Greenbrier International, Inc.
  • 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 January 19, 2019

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  • ACTIVE INGREDIENT

    Active ingredients

    Camphor            4.7%

    Menthol             1.25%

    Eucalyptus Oil     1.2%

  • PURPOSE

    Purpose

    Cough suppressant/topical analgesic

    Cough suppressant/topical analgesic

    Cough suppressant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves throat and chest

    • cough
    • nasal congestion due to common cold
    • aching muscles
    • minor aches and pains
  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

  • DO NOT USE

    Do not use

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

    Ask a doctor before use if you have

    • asthama
    • excessive phlegm (mucus)
    • emphysema
    • persistent or chronic cough
    • cough associated with smoking
  • WHEN USING

    When using this product do not

    • heat
    • microwave
    • use near open flame
    • 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

    • muscle aches/pain persist 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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • see important warnings under "When using this product"
    • children under 2 years of age, ask a doctor before using this product
    • adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.
  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ASSURED VAPORIZING CHEST RUB

    label

  • INGREDIENTS AND APPEARANCE
    ASSURED VAPORIZING CHEST RUB 
    camphor and eucalyptus oil and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-7991
    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
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 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:33992-7991-4113 g in 1 JAR; Type 0: Not a Combination Product06/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/26/2018
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(33992-7991)
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