Lidocaine Hci Cream
FDA Label NDC 73352-204

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 Lidocaine Hci (NDC 73352-204). 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 lidocaine hci 4% cream - topcial analgesic pain relieving cream, uses, warnings, directions, other information, inactive ingredients, questions or comments?, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Lidocaine Hci 4% Cream - Topcial Analgesic Pain Relieving Cream

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ How Supplied

→ Otc - Keep Out Of Reach Of Children

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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.

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