GELAZUL ROLL-ON- lidocaine hcl, menthol gel

GelAzul Roll-On by

Drug Labeling and Warnings

GelAzul Roll-On by is a Otc medication manufactured, distributed, or labeled by Laboratorio Pharma Internacional SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingedients

• Active Ingredient: Purpose
• Lidocaine Hydrochloride 4.0%: Topical Anesthetic
• Menthol 3.0%: Topical Anesthetic

Inactives

Alcohol, Carbomer, FD&C Blue 1, Methyl Salcylate, Purified Water, Triethanolamine

Warnings

For external use only.

Do Not Use:

With a bandage tight

In large quantities, particulary over raw surfaces or blistered areas

On wounds or damaged skin

Stop Use and Consult a doctor

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with in a few days.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center inmediateyly.

Uses

For temporarily relieve minor aches and pains of muscle and joins associated with simple backache, arthritis, strains, brices, and sprains.

Directions

Dosage

Adults and children 12 years and older

Apply to the affected area not more than three or four times daily.

GELAZUL

INGREDIENTS AND APPEARANCE

GELAZUL ROLL-ON 
lidocaine hcl, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73182-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73182-100-03	88.72 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2019

Labeler - Laboratorio Pharma Internacional SRL (816365775)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorio Pharma Internacional SRL		816365775	manufacture(73182-100)