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  5. Label Information: Xtracare Vaporizing Chest Rub

FDA Label for Xtracare Vaporizing Chest Rub

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. OTHER SAFETY INFORMATION
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Xtracare Vaporizing Chest Rub Product Label

The following document was submitted to the FDA by the labeler of this product China Ningbo Shangge Cosmetic Technology Corp.. 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                                                 Purpose

Camphor 4.8% ..................................... Cough Suppressant

Menthol 1.0% ............................................ Topical Analgesic


Otc - Purpose



Uses

  • on chest and throat, temporarily relieves cough as may occur with common cold and minor bronchial irritation.
  • for the temporary relief of pain associated with minor skin irritation.

Otc - Keep Out Of Reach Of Children



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


Indications & Usage



XtraCare® Vaporizing Chest Rub

Cough Suppressant

Net Wt 4 Oz (113 g)


Warnings



Warnings

For external use only; avoid contact with eyes.

Do not use

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

    • 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
      • 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

        • muscle aches and pains persist more than 7 days or come back
        • cough lasts more than 7 days, comes back, 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. 


Dosage & Administration



Directions

  • see important warnings under "When using this product"
  • adults and children 2 years old and older:
  • rub a thick layer on chest & throat or rub on sore aching muscles
  • 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 per 24 hours or as directed by doctor
  • children under 2 years: do not use

Inactive Ingredient



Inactive Ingredients:

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil


Other Safety Information



Other Information:store at room temperature

Questions/Comments?1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA


* Please review the disclaimer below.