Topicaine Ultra by Oncora Pharma, LLC TOPICAINE ULTRA gel

Topicaine Ultra by

Drug Labeling and Warnings

Topicaine Ultra by is a Otc medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TOPICAINE™ Ultra 2% – Lidocaine HCl 2% Gel

Oncora Pharma

NDC: 85477-307-85

Active Ingredient

Lidocaine HCl 2%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with:

• minor burns
  
• sunburn
  
• minor cuts
  
• scrapes
  
• insect bites
  
• minor skin irritations

Warnings

For external use only.

When using this product:

• Avoid contact with the eyes.
  
• Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if:

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

Directions

• Adults and children 2 years and older: Apply externally to the affected area up to 3–4 times daily.
  
• Children under 2 years: Do not use. Consult a doctor.

Other Information

Store at USP controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients

Inactive ingredients are printed on the product container label.

Aqua (Water), Hydroxyethylcellulose, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Lactic Acid.

See bottle label below for full ingredient listing.

Manufactured for: Oncora Pharma, Dallas, TX 75228

Principal Display Panel

NDC: 85477-307-85
Topicaine
Ultra External Gel 2%
Lidocaine 2%
Net Wt. 3 oz. (85g)

INGREDIENTS AND APPEARANCE

TOPICAINE ULTRA 
topicaine ultra gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85477-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-307-85	85 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/01/2026

Labeler - Oncora Pharma, LLC (119482542)