Topicaine Ultra Gel
FDA Label NDC 85477-307

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Topicaine Ultra (NDC 85477-307). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product:, stop use and ask a doctor if:, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Ndc: 85477-307-85topicaineultra External Gel 2%lidocaine 2%net Wt. 3 Oz. (85g) (Topicaine Ultra 01)

Ndc: 85477-307-85topicaineultra External Gel 2%lidocaine 2%net Wt. 3 Oz. (85g) (Topicaine Ultra 01)

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