Label: DELSYM NO MESS VAPOR ROLL ON (camphor- natural, eucalyptus oil, and menthol, unspecified form ointment

  • 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 April 15, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 5.3%Cough suppressant/topical analgesic
    Eucalyptus oil 1.3%Cough suppressant
    Menthol 2.8%Cough suppressant/topical analgesic
  • Uses

    temporarily relieves

    • cough due to minor throat and bronchial irritation as may occur with the common cold
    • cough to help you sleep
    • minor aches and pains of muscles and joints
  • Warnings

    For external use only

    Ask a doctor before use if you have

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

    When using this product

    • do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
    • do not take by mouth or place in nostrils
    • do not bandage tightly
    • avoid contact with eyes
    • do not apply to wounds or damaged skin

    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 condition.
    • muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • see important warnings under "When using this product"
    • adults and children 2 years of age and older
    • for cough, apply a thick layer on the throat and chest
    • cover with a warm, dry cloth if desired
    • clothing should be loose about throat and chest to help vapors reach the nose and mouth
    • for muscle aches and pains, apply to affected area
    • use up to three times daily or as directed by a doctor
    • children under 2 years: ask a doctor
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    fragrance, glyceryl dibehenate, light mineral oil, octyldodecyl olivate, petrolatum

  • Questions?

    1-866-682-4639

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 50 g Container Carton

    NEW
    NDC 72854-352-01

    Delsym®

    NO MESS
    VAPOR
    ROLL-ON
    Cough Suppressant & Topical Analgesic
    COUGH RELIEF

    100%
    Natural
    Camphor, Eucalyptus Oil,
    Menthol

    Ointment

    Ages 2+

    NET WT 1.76 OZ (50 g)

    Principal Display Panel - 50 g Container Carton
  • INGREDIENTS AND APPEARANCE
    DELSYM   NO MESS VAPOR ROLL ON
    camphor (natural), eucalyptus oil, and menthol, unspecified form ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)53 mg  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL13 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM28 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-352-011 in 1 CARTON07/01/2022
    150 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/01/2022
    Labeler - RB Health (US) LLC (081049410)
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