GERMA LINIMENTO UBRE PLUS- methyl salicylate 10% ointment

Germa Linimento Ubre Plus by

Drug Labeling and Warnings

Germa Linimento Ubre Plus by is a Otc medication manufactured, distributed, or labeled by Germa Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Methyl Salicylate 10%

Uses

For the temporary relief of minor aches and pains of muscles and joints.

Purpose

Topical Analgesic

Warnings

For external use only ■ Use only as directed

Warnings

KEEP OUT OF THE REACH OF CHILDREN

In case of an overdose, call a Poison Control center or get medical help right away.

If pregnant or Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Stop use and ask a Doctor immediately if

pain persists for more than 7 days, or redness is present, or in conditions affecting children under 12 years of age excessive irritation of the skin develops if prone to allergic reaction from any of the ingredients.

Other Information

Store at controlled room temperature 15-30ºC (59-86ºF)

Directions

Use only as directed. Adults and children 2 years and older; apply to the affected area no more than 3 to 4 times daily n Children under 2 years of age; consult a physician.

Inactive Ingredients

Capsaicin, Glyceryl Monoisostearate, Isothiazolinone, Menthol Crystals, Mineral Oil, MSM, Propylene Glycol, and Stearic Acid.

When Using this product

Avoid contact with eyes Do not bandage tightly Do not apply to wounds or broken skin If the condition worsens and if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMA LINIMENTO UBRE PLUS 
methyl salicylate 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-5800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
MENTHOL (UNII: L7T10EIP3A)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
ISOTHIAZOLINONE (UNII: E57JT172V7)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-5800-6	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/29/2019

Labeler - Germa Products, LLC (116626935)