POINT RELIEF LIDOSPOT WITH MENTHOL- lidocaine, menthol patch

Point Relief LidoSpot with Menthol by

Drug Labeling and Warnings

Point Relief LidoSpot with Menthol by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises, Foshan Aqua Gel Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

PURPOSE

Topical Anesthetic

USES

Temporary relief of minor pain

WARNINGS

• For External use only. Use only as directed.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

If pregnant or breast feeding

• Contact a physician prior to use.

WHEN USING:

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor if

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS Adults and children 12 years of age and over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
Children under 12 years of age: consult a physician.

INACTIVE INGREDIENTS

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,
propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

STORAGE AND HANDLING

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Manufactured For:Fabrication Enterprises IncWhite Plains, NY 10602www.FabEnt.com

INGREDIENTS AND APPEARANCE

POINT RELIEF LIDOSPOT WITH MENTHOL 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-912
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-912-05	5 in 1 POUCH	07/01/2018
1		8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2018

Labeler - Fabrication Enterprises (070577218)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(51452-912)