Trilogel
FDA Label NDC 73352-620

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifluent Pharma Llc for the product Trilogel (NDC 73352-620). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Lidocaine HCl, USP 2.8%

Purpose

Topical analgesic

Uses

For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

Warnings

For external use only

Otc - Do Not Use

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

Stop use and ask a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Do not use; consult a physician.

Other Information

Store at 20-25°C (68-77°F). Protect from freezing.

Inactive Ingredients

Caprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

Questions Or Comments?

(210) 944-6920

Principal Display Panel - 57 G Pouch Label

Tear at notch to open. Do not use if seal is broken.

NDC: 73352-620-01

TRIFLUENT
PHARMA™

Trilogel™

Lidocaine HCl 2.8%

Topical Analgesic Gel

For the temporary relief of pain associated with minor burns, sunburn,
minor cuts, scrapes, insect bites, and minor skin irritations.

NET WT. 2 OZ. (57 G)

Principal Display Panel (57 G Pouch Label)

Principal Display Panel (57 G Pouch Label)

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