Predator

Predator
SPL v3
SPL
SPL Set ID c0599e61-3f54-46ad-9d9c-959ca00f5014
Route
TOPICAL
Published
Effective Date 2013-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (400 mg)
Inactive Ingredients
Water Arnica Montana Flower C13-14 Isoparaffin Chondroitin Sulfate (bovine) Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Laureth-7 Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Stearic Acid Triethanolamine Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-11

Description

This product is not to be administered orally (mouth) or in the ocular (eye) area. If used improperly by oral administration the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, any device (including hands and fingers) used to administer this product topically should be cleaned well before possible contact with eyes, intra-nasaly or mouth.


Medication Information

Dosage and Administration

Rub 1ml in cicular motion for 60 seconds on effected area.

Description

This product is not to be administered orally (mouth) or in the ocular (eye) area. If used improperly by oral administration the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, any device (including hands and fingers) used to administer this product topically should be cleaned well before possible contact with eyes, intra-nasaly or mouth.

Section 50565-1

This product should be kept out of the reach of children uner twelve (12) years of age.

Section 51945-4

Section 55105-1

Pain relief

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

Active Ingredients

lidocaine HCL 4%

Method of Application

Rub 1ml in circular motion for 6 0seconds on effected area.

Information for Patients

This product is not to be administered orally (mouth) or in the ocular (eye) area.

If used improperly by oral administration the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, any device (including hands and fingers) used to administer this product topically should be cleaned well before possible contact with eyes, intra-nasaly or mouth.


Structured Label Content

Dosage and Administration (34068-7)

Rub 1ml in cicular motion for 60 seconds on effected area.

Section 50565-1 (50565-1)

This product should be kept out of the reach of children uner twelve (12) years of age.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain relief

Other Ingredients (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

Active Ingredients (active ingredients)

lidocaine HCL 4%

Method of Application

Rub 1ml in circular motion for 6 0seconds on effected area.

Information for Patients

This product is not to be administered orally (mouth) or in the ocular (eye) area.

If used improperly by oral administration the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, any device (including hands and fingers) used to administer this product topically should be cleaned well before possible contact with eyes, intra-nasaly or mouth.


Advanced Ingredient Data


Raw Label Data

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