FDA Label for Lidocaine Hci
View Indications, Usage & Precautions
Lidocaine Hci 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.
Lidocaine Hci 4% Cream - Topcial Analgesic Pain Relieving Cream
Active Ingredient
Lidocaine HCI 4%...................................Topical analgesic
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac.
Warnings
- For external use only
- Avoid contact with 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, discontinue use or this product and consult a doctor.
If pregnant or breast-feeding, ask a health professional before use.
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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 doctor.
Other Information
Store at room temperature 68° to 77°F (20 to 25°C); excursion permitted to 58°F to 86°F (15° to 30°C)
Inactive Ingredients
Alkyl (C12-15) Benzoate, Butylparaben, Carica Papaya (Papaya) Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Disodium EDTA, Emulsifying Wax, Ethylparaben, Glycerin, Glyceryl Stearate , Hydrogenated Polydecene, Hydroxypropylcellulose, Isobutylparaben, Lavandula Angustifolia (Lavender) Flower Extract, Methylparaben, PEG 100, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Lactate, Sodium Polyacrylate, Trideceth-6, Xanthan Gum
Questions Or Comments?
(210) 944-6920
How Supplied
Lidocaine HCI 4% Cream
NDC 73352-204-60
1oz. (30g) tube
MANUFACTURED FOR:
Trifluent Pharma, LLC
San Antonio, TX 78213
204-60
REV01 08/2025
Otc - Keep Out Of Reach Of Children
KEEP out of reach of children. If swallowed, get medical help anor contact a Poison control Center (1-800-222-1222) right aways.
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