Active Ingredient
Methyl Salicylate 10%
Germa Manteca Ubre Plus (red) Ointment
FDA Label NDC 73635-5804
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 Manteca Ubre Plus (red) (NDC 73635-5804). 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
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.
Indications & Usage
When using this product do not • heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns • use on eyes or directly on mucous membranes • take by mouth or place in nostrils • apply to wounds or damaged skin • use on bandage skin • use, store, pour or spill near heat or open flame.
Purpose
Topical Analgesic
Warnings
For external use only ■ Use only as directed
Do not use • on children • with a heating pad • with a tight bandage • on eyes, mucous membranes, wound or irritated skin • over extensive areas of the body.
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 breast-feeding, ask a health professional before use.
Otc - Ask Doctor
Consult a doctor and discontinue use • If condition worsens or symptoms persist for more than 7 days • If you have sensitive skin • if prone to allergic reaction from any of the ingredients.
Other Information
Store at controlled room temperature 15-30°C (59-86°F)
Directions
Clean skin of lotions, creams, ointments, liniment or sprays • Apply liberally to affected area and massage until absorbed into skin • Do not apply more than 3 or 4 times daily. • Children under 12 years of age, ask a doctor.
Inactive Ingredients
Camphor, D&C Color Red #17, Eucalyptus Oil, Lanolin Oil, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum.
Package Label.Principal Display Panel
Ubre Plus Red (Ubre Plus Red)
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