GERMA GEL DEL ARTICO- menthol 1% ointment

Germa Gel del Artico by

Drug Labeling and Warnings

Germa Gel del Artico 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

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 Red #17, Eucalyptus Oil, Lanolin Oil, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum.

Principal Display Panel

INGREDIENTS AND APPEARANCE

GERMA GEL DEL ARTICO 
menthol 1% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-5802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOTHIAZOLINONE (UNII: E57JT172V7)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-5802-9	255.14 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	M017	03/29/2019

Labeler - Germa Products, LLC (116626935)