Vaporizing Chest Rub Ointment
FDA Label NDC 84809-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lj Pharma for the product Vaporizing Chest Rub (NDC 84809-007). 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 active ingredient                                   purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                   Purpose

Camphor 4.7%                                     Cough suppressant & topical analgesic

Eucalyptus oil 1.2%                               Cough suppressant

Menthol 1.25%                                      Cough suppressant & topical analgesic

Uses

When applied to chest or throat: Temporarily relieves cough due to minor throat and bronchial irritation associated with a common cold

When applied to muscles and joints: Temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only

Ask a doctor before use if you have:

  • A cough with too much phlegm (mucus)
  • Chronic cough that lasts or 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 burns
    • Take by mouth or place in nostrils Use in or near eyes
    • Apply to wounds or damaged skin
    • Bandage tightly
    • Use with other topical pain relievers

      • Stop Use and Ask a Doctor If

      • Muscle aches and pains worsen or last more than 7 days Symptoms clear up and then return within a few days
      • Cough persists more than 1 week, tends to recur, or is accompanied by: Fever, Rash, Persistent headache A persistent cough may be a sign of a serious condition
      • Redness or irritation develops

        • 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.

Directions

See important warnings under "When using this product" For Cough Suppression:

Adults and children 2 years and older:

▪ Rub on the throat and chest in a thick layer

▪ Cover with a warm, dry cloth if desired

▪ Clothing should be loose around throat and chest to help vapors reach the nose and mouth

▪ Use up to 3 times daily or as directed by a doctor

Children under 2 years of age:

▪ Ask a doctor

For Muscle & Joint Minor Aches and Pains:

Adults and children 2 years and older:

▪ Clean affected area before applying

▪ Apply to affected area no more than 3 to 4 times daily

Children under 2 years of age:

▪ Consult a doctor

Other Information

  • Store at room temperature

Inactive Ingredients

Cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

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