ASSURED PAIN RELIEF- lidocaine gel

Assured Pain Relief by

Drug Labeling and Warnings

Assured Pain Relief by is a Otc medication manufactured, distributed, or labeled by Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Lidocaine 4%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses  temporarily releives minor pain

WARNINGS

Warnings  for external use only.

Do not use

more than one patch on your body at a time or on cut  on wounds or damaged skin  with a heating pad

When using this product

avoid contact with eyes, mucous membranes or rashes  use only as directed  do not bandage tightly

do not use at the same time as other topical analgesics  dispose of used patch in a manner that always keeps products away from children and pets

Stop  use and ask a doctor if

you experience signs of skin injury, such as pain, swelling or blistering where product was applied symptoms persist for more than 7

days or clear up and occur again within a few days  condition worsens  redness is present  irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions  Adults and children 12 years of age and over:

Clean and dry affected area  Remove film from patch and apply to the skin (see package for instructions)

Apply to affected area not more than 3 to 4 times daily  Remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a physician

STORAGE AND HANDLING

Other information

Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight  Protect product from excessive moisture

INACTIVE INGREDIENT

Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,

PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED PAIN RELIEF 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69159-100
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

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69159-100-01	15 g in 1 PATCH; Type 0: Not a Combination Product	08/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/20/2017

Labeler - Foshan Aqua Gel Biotech Co., Ltd., (529128763)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(69159-100)