Xtracare Vaporizing Chest Rub Gel
FDA Label NDC 57337-051

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Vaporizing Chest Rub (NDC 57337-051). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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