Chest Rub Gel
FDA Label NDC 52920-133

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Singhfam Corporation for the product Chest Rub (NDC 52920-133). 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 - ask doctor, otc - do not use, otc - stop use, otc - keep out of reach of children, 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            4.8%

Menthol              2.6%

Eucalyptus Oil    1.2%

Otc - Purpose

Purpose

Cough Suppressant

Nasal Decongestant

Topical Analgesic

Indications & Usage

Uses

Temporarily releives symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

    • Temporarily relives minor aches and pains of muscles.

Warnings

Warnings

For external use only. Avoid contact with eyes.

Otc - Ask Doctor

Ask a doctor before use if you have,

  • chronic cough that lasts or as occurs with smoking, asthma, or emphysema
  • cough with excessive phlegm (mucus)

Otc - Do Not Use

Do not use this product

  • near an open flame
  • by adding water
  • by mouth
  • in a microwave oven
  • on wounds or damaged skin
  • with tight bandages
  • in nostrils
  • added to hot water or any container where you are heating water
  • may cause splattering and results in burns

Otc - Stop Use

Stop use and ask a doctor if:

  • if muscle aches and pains persist for 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
  • if pregnant or breast-feeding, consult a physician before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions: see important warnings under “Do not use this product”

children under 2 years of age, ask a doctor

adults and children 2 years  of age or older:

  • rub a thick layer on chest and throat
  • if desired, loosely cover with a soft dry cloth but keep clothing loose
  • repeat up to 3 times daily, or as directed by a doctor

Inactive Ingredient

Inactive Ingredients

Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Parrafin.

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

CHEST RUB VAPORIZING ACTION GEL

NASAL DECONGESTANT AND COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

Label (Chest Rub)

Label (Chest Rub)

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