Health Smart Vaporizing Chest Rub Gel
FDA Label NDC 30400-702

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt Ltd. for the product Health Smart Vaporizing Chest Rub (NDC 30400-702). 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             1.0%

Eucalyptus Oil   1.0%

Otc - Purpose

Purpose

Cough Suppressant

Topical Analgesic

Nasal Decongestant

Indications & Usage

Uses

  • On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation.
  • For the temporary relief of pain associated with minor skin irritation.

Warnings

Warnings

For external use only. Avoid contact with eyes.

Do not take by mouth or place in nostrils.

Otc - Do Not Use

Do not use

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

  • with persistent or chronic cough such as occurs with asthma, emphysema or smoking

Otc - Ask Doctor

Ask doctor if you have,

  • cough that occurs with too much phlegm (mucus)

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  that lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions

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: see important warnings under “When using this product”

adults and children 2 years and over:

  • rub a thick layer on chest and throat
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth
  • use up to 3 times daily as directed by doctor

    • children under 2 years of age: ask a doctor

Inactive Ingredient

Inactive Ingredients

Petrolatum, Mineral Oil,  Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

Other

PRINCIPAL DISPLAY PANEL

HEALTH SMART VAPORISING CHEST RUB GEL

DECONGESTANT AND COUGH SUPPRESSANT

NET WT.4 OZ (113g)

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