Active Ingredient
Menthol 1.8%
Germa Vapozol Ointment
FDA Label NDC 73635-5801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germa Products, Llc for the product Germa Vapozol (NDC 73635-5801). 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 ingredient, uses, indications & usage, purpose, warnings, otc - pregnancy or breast feeding, otc - ask doctor, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Uses • on chest and throat, temporarily relieves cough due to the common cold. • on muscles and joints, temporarily relieves minor aches and pains.
Indications & Usage
When using this product, do not • heat n microwave • add to hot water or any container where heating water may cause splattering and result in burns.
Purpose
Cough Suppressant & Topical Analgesic
Warnings
For external use only • Avoid contact with the eyes. Do not use • by mouth • with tight bandages • in nostrils • on wounds or damaged skin • Do not use if safety seal is torn, broken or missing.
Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center, right away.
Otc - Pregnancy Or Breast Feeding
Stop use and ask a doctor if pregnant or breastfeeding.
Otc - Ask Doctor
Stop use and ask a doctor if • muscle aches and pains persist more than 7 days or come back • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. • pregnant or breastfeeding.
Ask a doctor before use if you have n cough that occurs with too much phlegm (mucus) n persistent or chronic cough such as occurs with smoking, asthma or emphysema.
Other Information
Store at controlled room temperature 15-30°C (59-86°F)
Directions
Directions • see important warnings under “When using this product” • adults and children 2 years and over; • rub a thick layer on chest & throat or rub on sore aching muscles • cover with a warm, dry cloth if desired • keep clothing loose about throat/chest to help vapors reach the nose/mouth • repeat up to three times per 24 hours or as directed by doctor • not intended for use by persons under the age of 18.
Inactive Ingredients
White petrolatum, camphor, eucalyptus oil, nutmeg oil.
Package Label.Principal Display Panel
Vapozol (Vapozol)
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