GERMA UBRE MASTITIS- methyl salicylate 2% ointment

Germa Ubre Mastitis by

Drug Labeling and Warnings

Germa Ubre Mastitis 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 2%

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.

Warnings

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.

PREGNANCY OR BREAST FEEDING

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

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 15-30ºC (59-86ºF)

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMA UBRE MASTITIS 
methyl salicylate 2% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-5807
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
D&C BROWN NO. 1 (UNII: 8796B4I6HE)
LANOLIN OIL (UNII: OVV5IIJ58F)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ICHTHAMMOL (UNII: NQ14646378)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-5807-2	56.69 mL in 1 JAR; 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	M014	03/29/2019

Labeler - Germa Products, LLC (116626935)