GERMA LINIMENTO UBRE PLUS (ROLL-ON)- methyl salicylate 10% ointment

Germa Linimento Ubre Plus (Roll-On) by

Drug Labeling and Warnings

Germa Linimento Ubre Plus (Roll-On) 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 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

Warnings

KEEP OUT OF THE REACH OF CHILDREN

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

PREGNANCY OR BREAST FEEDING

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

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 15-30ºC (59-86ºF)

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

Capsaicin, Carbomer, Eucalyptus Oil, Isopropyl Alcohol, Menthol Crystals, Polysorbate 20, Propylene Glycol, Triethanolamine and Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMA LINIMENTO UBRE PLUS (ROLL-ON) 
methyl salicylate 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-5806
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
TROLAMINE (UNII: 9O3K93S3TK)
CAPSAICIN (UNII: S07O44R1ZM)
MENTHOL (UNII: L7T10EIP3A)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-5806-3	88.5 mL in 1 APPLICATOR; 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)