Predator
FDA Label NDC 54723-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Predator (NDC 54723-101). 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 warnings, active ingredients, other ingredients, otc - keep out of reach of children, otc - purpose, dosage & administration, uses, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

For external use only

Avoid contact with eyes

If symptoms persist for more than seven days, or clear up and occur again within a few days, discontinue use and consult physician

If redness, irritation, swelling, pain or ot5her symptoms increase, discontinue use and consult physician

If swallowed consult physician.

Active Ingredients

lidocaine HCL 4%

Other Ingredients

Aqua, Amica Montana Extract, C13-14 Isoparafin, Chondrotin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth 7, Melaleuca Alternifoil (Tea Tree) oil, Methylsulfonylmethana (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

External anesthetic

Dosage & Administration

For adults and children two years or older, apply externally to the affected area. Do not use more than three to four times per day.

Uses

For temporary relief of pain and itching and minor skin irratations due to minor cuts and scrapes, sunburn and minor burns. Also used for temporary relief of itching associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak and poison sumac, soaps, detergetns, cosmetics and jewelry.

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