FDA Label for Trilogel

View Indications, Usage & Precautions

Trilogel Product Label

The following document was submitted to the FDA by the labeler of this product Trifluent Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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)


* Please review the disclaimer below.