GERMA MANTECA UBRE PLUS (TIN)- methyl salicylate 10% ointment

Germa Manteca Ubre Plus (TIN) by

Drug Labeling and Warnings

Germa Manteca Ubre Plus (TIN) 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

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.

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.

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

Camphor, D&C Color Yellow #11, Eucalyptus Oil, Lanolin Oil, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum.

Principal Display Panel

INGREDIENTS AND APPEARANCE

GERMA MANTECA UBRE PLUS (TIN) 
methyl salicylate 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-5805
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
TEA TREE OIL (UNII: VIF565UC2G)
MENTHOL (UNII: L7T10EIP3A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LANOLIN OIL (UNII: OVV5IIJ58F)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-5805-3	85.5 mL in 1 CAN; 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)