Collavera by Oncora Pharma, LLC COLLAVERA gel

Collavera by

Drug Labeling and Warnings

Collavera by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Collavera™ contains Lidocaine Hydrochloride 20 mg/g (2%) in a topical gel base.

INDICATIONS AND USAGE

Collavera™ is indicated for topical analgesia as directed by a healthcare provider.

WARNINGS

For external use only. Not for ophthalmic use.

Avoid contact with eyes.

Excessive application may result in systemic absorption. Use only as directed.

Keep out of reach of children.

OVERDOSAGE

Excessive topical application may increase systemic absorption of lidocaine and may result in central nervous system and cardiovascular effects. In the event of overdose, discontinue use and seek medical attention.

DOSAGE AND ADMINISTRATION

For topical use only.

Apply a thin layer to the affected area 3 to 4 times daily or as directed by a healthcare provider.

Avoid contact with eyes and mucous membranes.

HOW SUPPLIED

Collavera™ (Lidocaine Hydrochloride 20 mg/g) is supplied as a clear topical gel in a 1 oz (28.33 g) tube.

NDC: 85477-305-07

PRINCIPAL DISPLAY PANEL

pdp

INGREDIENTS AND APPEARANCE

COLLAVERA 
collavera gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-305-07	28.33 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/26/2026

Labeler - Oncora Pharma, LLC (119482542)