POINT RELIEF LIDOSPOT- lidocaine hcl, menthol patch

Point Relief LidoSpot by

Drug Labeling and Warnings

Point Relief LidoSpot by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Lidocaine HCl 4%

Menthol 1%

PURPOSE

Topical Anesthetic

External Anesthetic

USES

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

WARNINGS

• For External use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• If symptoms persist for more than 7 days, discontinue use and consult a physician
• If swallowed, consult a physician.

• Keep out of reach of children. Consult a physician prior to using on children under 12.

• Do not apply to open wounds or damaged skin.
• Do not use oils, lotions or powders on treatment area prior to application.
• Do not use with any bandage, wrap, stocking or similar device or garment.

• If pregnant or breast feeding, contact a physician prior to use.

DIRECTIONS

• Apply to treatment area.
• How to apply:
• Clean and dry treatment area.
• If customized size is needed, cut patch to the desired size/shape with scissors.
• Remove protective backing from patch to expose active ingredient and adhesive.
• Apply patch to treatment area.
• Use only one patch at a time. Use a maximum of four patches per day.
• Leave patch on treatment area for up to 12 hours.
• Do not use patches for longer than 5 consecutive days.

OTHER INGREDIENTS

Water, Glycerol, Sodium polyacrylate, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Aluminiumglycinate, Titaniumdioxide, Kaolin, Tween 80, Propylene glycol, Tartaric acid, PVP, Polyacrylic acid, Methylparaben, Propylparaben.

STORAGE AND HANDLING

Store at room temperature

Avoid direct sunlight

Representative Labeling

INGREDIENTS AND APPEARANCE

POINT RELIEF LIDOSPOT 
lidocaine hcl, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-727
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
KAOLIN (UNII: 24H4NWX5CO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-727-01	5 in 1 POUCH	03/02/2016
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	03/02/2016

Labeler - Fabrication Enterprises (070577218)