Active Ingredient
Camphor 10%
Germa Camphor Ointment
FDA Label NDC 73635-5809
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 Camphor (NDC 73635-5809). 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
Temporary relief of minor pain • Rheumatism • Muscular aches • Arthritis • Backache
Indications & Usage
Do not use • on children • on irritated skin • in or near eyes or mucous membranes • on wounds or damaged skin • if prone to allergic reaction from any of the ingredient • on large areas of the body. • if you are taking any other medication or drinking alcohol • if safety seal is torn, broken or missing.
Purpose
Topical Analgesic
Warnings
For external use only
Do not use • on children • on irritated skin • in or near eyes or mucous membranes • on wounds or damaged skin • if prone to allergic reaction from any of the ingredient • on large areas of the body. • if you are taking any other medication or drinking alcohol • if safety seal is torn, broken or missing.
KEEP OUT OF THE REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding • ask a health professional before use.
Otc - Ask Doctor
Stop use and ask a doctor • if condition worsens or cleans up and occurs again • if symptoms persist for more than 7 days or irritation or severe burning occurs.
Other Information
Store at controlled room temperature 15-30°C (59-86°F)
Directions
Adults; 18 years of age and older, apply in affected area not more than 3 times daily.
Inactive Ingredients
Petrolatum
Package Label.Principal Display Panel
Camphor Ointment (Camphor)
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