Label: MEDICATED CHEST RUB (camphor- synthetic, 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 February 16, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Camphor 4.8%Cough suppressant & topical analgesic
    Eucalyptus oil 1.2%Cough suppressant
    Menthol 2.6%Cough suppressant & topical analgesic
  • Uses

    • on chest & throat, temporarily relieves cough due to the common cold
    • on muscles and joints, temporarily relieves minor aches and pains
  • Warnings

    For external use only; avoid contact with eyes.

    Do not use

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

    Ask a doctor before use if you have

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

    When using this product

    • do not heat
    • do not microwave
    • do not add to hot water or any container where heating water. May cause splattering and result in burns.

    Stop use and ask a doctor if

    • muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days
    • cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    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: 800-222-1222.

  • Directions

    see important warnings under "When using this product"

    • Adults and children 2 years old and older:
      • rub a thick layer on chest & throat for cough, or rub on sore aching muscles or joints
      • cover with a warm, dry cloth if desired
      • keep clothing loose about throat/chest to help vapors reach the nose/mouth
      • repeat up to three times daily or as directed by a doctor
    • Children under 2 years: do not use
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON JAR IS BROKEN OR MISSING.
  • Inactive ingredients

    cedarleaf oil, nutmeg oil, spirits of turpentine, thymol, white petrolatum

  • Questions or comments?

    866-323-0107

  • SPL UNCLASSIFIED SECTION

    Distributed by: Geiss, Destin & Dunn, Inc.
    Peachtree City, GA 30269

  • PRINCIPAL DISPLAY PANEL - 100 g Jar Label

    GOODSENSE®
    NDC# 50804-078-01

    Medicated
    Chest Rub

    • Nasal Decongestant
    • Cough Suppressant
    • Topical Analgesic

    Compare to active ingredients of
    Vicks® VapoRub®*

    100%
    SATISFACTION
    GUARANTEED

    NET WT 3.53 OZ (100 g)

    Principal Display Panel - 100 g Jar Label
  • INGREDIENTS AND APPEARANCE
    MEDICATED CHEST RUB 
    camphor (synthetic), eucalyptus oil, and menthol, unspecified form ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.048 g  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.012 g  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.026 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    THYMOL (UNII: 3J50XA376E)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-078-01100 g in 1 JAR; Type 0: Not a Combination Product02/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/11/2021
    Labeler - GOODSENSE (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(50804-078)