Antibacterial
FDA Label NDC 29500-903

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products Llc for the product Antibacterial (NDC 29500-903). 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, otc - keep out of reach of children, dosage & administration, inactive ingredient, warnings, indications & usage, package label.principal display panel, 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

Otc - Keep Out Of Reach Of Children



Do not use on children under 2 years unless directed by doctor

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;

do not use on children under 2 years unless directed by doctor


Inactive Ingredient



Inactive ingredients

cedar leaf oil, mineral oil, nutmeg oil, petrolatum, thymol, turpentine oil.

Warnings



Warnings

For external use only, avoid contact with eyes.

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

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

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.

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 and pain persist more than 7 days or come back.

Indications & Usage

Uses on chest and throat, helps temporarily relieve, decrease, suppress, quiet and alleviate cough as may occur with common cold and minor bronchial irritation.

Package Label.Principal Display Panel

Label (Chestrub)

Label (Chestrub)


Personal Care

Vaporizing Chest Rub Cough Suppressant

Net Wt. 4 oz (113 g)

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