Lubracane by Ozeion LLC / Abbe Laboratories, Inc LUBRACANE gel

Lubracane by

Drug Labeling and Warnings

Lubracane by is a Otc medication manufactured, distributed, or labeled by Ozeion LLC, Abbe Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 0.24% Topical Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis and minor injuries including sprains, strains and bruises.

WARNINGS

Warnings

For external use only. Avoid contact with eyes and open wounds. Do not use if allergic to any of its ingredients.

​Keep out of reach of children.​ If swallowed, get medical help or contact Poison Control immediately.

Do Not Use

If pregnant, breast feeding or intending to become pregnant.

Precautions

Stop use and consult a physician if pain persists beyond 3 days, a rash or irritation develops, or if condition worsens, or resolves and then returns. 

Directions

Adults and Children over 12. Apply an adequate amount of gel to cover affected area. On day 1 apply 2 to 3 times within the first hour, and up to six times that day. On the following days, apply 3 to 4 times a day, as needed. 

Inactive Ingredients

Filtrated deionized water, MethylSulfonylMethane (MSM), Acrylates/C-10-30, Alkyl Acrylate Crosspolymer, Polysorbate-20, Propylene Glycol (and) Dizolidinyl Urea (and) Iodopropynyl Butylcarbamate, Ammonium Hydroxide. 

Other Information

Store between 68° and 74°F (20°-23°C) with closed cover. Do not apply with hot pack. 

Questions or Comments

Email us at: info@lubracane.com

Label 

INGREDIENTS AND APPEARANCE

LUBRACANE 
lubracane gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72235-5838
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.24 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
AMMONIA (UNII: 5138Q19F1X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72235-5838-1	118.3 mL in 1 JAR; Type 0: Not a Combination Product	01/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/15/2018

Labeler - Ozeion LLC (067331308)

Establishment
Name	Address	ID/FEI	Business Operations
Ozeion LLC		067331308	manufacture(72235-5838)