Universal Vaporizing Chest Rub Ointment
FDA Label NDC 52000-113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Universal Vaporizing Chest Rub (NDC 52000-113). 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   1.0%

Otc - Purpose

Purpose

Decongestant

Indications & Usage

Uses

  • on chest and throat, helps temporarily relive cough due to common cold.
  • on joints and muscles, temporarily relives 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
  • with tight bandages
  • on wounds or damaged skin

Otc - Ask Doctor

Ask doctor before use if you have,

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma, emphysema, or smoking

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 results in burns

Otc - Stop Use

Stop use and ask a doctor if

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

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

Adults and Children 2 years and over

  • rub a thick layer on chest and throat or rub on sore aching muscles
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth
  • repeat up to 3 times per 24 hours or as directed by doctor

    • Children under 2 years: do not use on unless directed by doctor

Inactive Ingredient

Inactive ingredients

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

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

UNIVERSAL VAPORISING CHEST RUB
NASAL DECONGESTANT AND COUGH SUPPRESSANT
NET WT.4 OZ (113g)

Label (Vaporising Chest Rub)

Label (Vaporising Chest Rub)

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