Active Ingredient
Methyl Salicylate 2%
Germa Ubre Mastitis Ointment
FDA Label NDC 73635-5807
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 Ubre Mastitis (NDC 73635-5807). 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 n joint & muscular aches n strains & sprain n backache.
Indications & Usage
Do not use, if prone to allergic reaction from any of the ingredients.
Do not use n on children • on irritated skin • in or near eyes or mucous membranes • on wounds or damaged skin.
Purpose
Topical Analgesic
Warnings
For external use only
Do not use 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, get help or contact a Poison Control Center immediately.
Do not use • on children • on irritated skin • in or near eyes or mucous membranes • on wounds or damaged skin n if prone to allergic reaction from any of the ingredient n on large areas of the body. • if you are taking any other medication or drinking alcohol • if safety seal is torn, broken or missing.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Ask Doctor
Stop use and ask a doctor n if condition worsens or cleans up and occurs again n 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 and children 12 years and older; apply to the affected area • no more than 3 to 4 times daily n children under 12 years of age; ask a Doctor.
Inactive Ingredients
Camphor crystals, D&C Brown #1, Lanolin, Ichthammol, and white petrolatum.
Package Label.Principal Display Panel
Ubre Mastitis (Ubre Mastitis)
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