GERMA LINIMENTO UBRE PLUS (ROLL-ON)- methyl salicylate 10% ointment 
Germa Products, LLC

----------

Germa Linimento Ubre Plus Roll-On

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.

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.

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

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.

Ubre Plus Roll-On

GERMA LINIMENTO UBRE PLUS (ROLL-ON) 
methyl salicylate 10% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73635-5806
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73635-5806-388.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product03/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/29/2019
Labeler - Germa Products, LLC (116626935)

Revised: 10/2023
Document Id: 0816bd3e-365f-cf68-e063-6394a90aa661
Set id: bfddff61-f6b4-ba9f-e053-2995a90ac9c0
Version: 3
Effective Time: 20231019
 
Germa Products, LLC