Label: BABYGANICS COLD RELIEF CHEST RUB- menthol stick

  • 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 23, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 2.6%

  • Purpose

    Cough suppressant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • suppresses the impulse to cough to help you sleep
  • Warnings

    For external use only. Avoid contact with eyes.

    Do not use

    • by mouth
    • in nostrils

    Ask a doctor before use if your child has

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

    When using this product do not

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

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

    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"
    • children 2 to under 12 years of age:
      • apply a thick layer on chest & throat
      • cover with a warm, dry cloth if desired
      • keep clothing loose about throat/chest to help vapors reach the nose and mouth
      • repeat up to 3 times per 24 hours or as directed by doctor
    • children under 2 years of age: ask a doctor
  • Other information

    • store at room temperature 59-77°F (15-25°C)
    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    beeswax, cedrus atlantica bark oil, eucalyptus globulas leaf oil, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, lavandula angustifolia (lavender) oil, olea europaea (olive) fruit oil, ricinus communis (castor) seed oil, rosmarinus officinalis (rosemary) leaf extract, silica, tocopherol

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    KAS Direct, LLC.
    Hicksville, NY 11801

  • PRINCIPAL DISPLAY PANEL - 18 g Tube Box

    babyganics®

    cold relief chest rub

    with natural menthol ∙ cough suppressant
    non-allergenic ∙ pediatrician &
    dermatologist tested

    no: parabens, phthalates, mineral oil,
    petrolatum, artificial fragrances or dyes

    0.64 OZ(18g)

    Principal Display Panel - 18 g Tube Box
  • INGREDIENTS AND APPEARANCE
    BABYGANICS COLD RELIEF CHEST RUB 
    menthol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1286
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSEMARY (UNII: IJ67X351P9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1286-11 in 1 BOX08/15/2013
    118 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/15/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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