Avedana Medicated Chest Rub
FDA Label NDC 43749-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Medicated Chest Rub (NDC 43749-110). 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 ingredients, uses, warnings, do not use, ask a doctor before use if you have, if pregnant or breast-feeding, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Ingredients                   Purpose

Camphor 4.8%             cough suppressant/topical analgesic

Eucalyptus Oil 1.2%      cough suppressant

Menthol 2.6%               cough supressant/topical analgesic

Uses

Uses - On chest and throat, temporarily relieves cough due to common cold.  On the muscles and joints, temporarily relieves minor aches and pains.

Warnings

Warnings

For external use only.  Avoid contact with eyes.

Do Not Use

Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages

Ask A Doctor Before Use If You Have

asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking

If Pregnant Or Breast-Feeding

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

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Directions

- children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on throat and chest or rub on sore aching muscles.  If desired cover with a dry soft cloth, but keep clothing loose.  Repeat up to 3 times a day.

Other Information

store at room temperature

Other Ingredients

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

Purpose

cough suppressant / topical analgesic, cough suppressant

Product Label

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