Assured Vaporizing Chest Rub Ointment
FDA Label NDC 33992-7991

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Vaporizing Chest Rub (NDC 33992-7991). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, 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

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil     1.2%

Otc - Purpose

Purpose

Cough suppressant/topical analgesic

Cough suppressant/topical analgesic

Cough suppressant

Indications & Usage

Uses

Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains

Warnings

Warnings

For external use only. Avoid contact with eyes.

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • asthama
  • excessive phlegm (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking

Otc - When Using

When using this product do not

  • heat
  • microwave
  • use near open flame
  • 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

  • muscle aches/pain persist more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

Dosage & Administration

Directions

  • see important warnings under "When using this product"
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.

Other

Other information

  • Store at room temperature

Inactive Ingredient

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

Label (Vaporising Chest Rub)

Label (Vaporising Chest Rub)

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