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  5. Label Information: Chest Rub Vaporizing

FDA Label for Chest Rub Vaporizing

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chest Rub Vaporizing Product Label

The following document was submitted to the FDA by the labeler of this product North & South Wholesalers Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%


Otc - Purpose



Purpose

Decongestant


Indications & Usage



Uses

  • on chest and throat, helps temporarily relieve cough due to common cold
  • on joints and muscles, temporary relieves minor aches and pain

Warnings



Warnings

For external use only, avoid contact with eyes.


Otc - Do Not Use



Do not use

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

Otc - 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

Otc - When Using



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

Otc - Stop Use



Stop use and ask a doctor if:

  • cough lasts more than 7 days, comes back, or fever, rash or persistent headache. These could be sign of a serious conditions
  • muscle aches and pain persist more than 7 days

Otc - 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 leaf oil, nutmeg oil, paraffin, petrolatum, thymol, and turpentine oil


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

CHEST RUB VAPORIZING GEL

NASAL DECONGESTANT

COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

label - chest rub

label - chest rub


* Please review the disclaimer below.