CORALITE LIDOCAINE PAIN RELIEF- lidocaine patch

Coralite Lidocaine Pain Relief by

Drug Labeling and Warnings

Coralite Lidocaine Pain Relief by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                          Purpose

Lidocaine 4%...............................................Topical analgesic

PURPOSE

Uses

temporarily relieves minor pain

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

WHEN USING

When using this product

• use only as directed. Read and follow all directions and warnings on this pouch.
• do not allow contact with the eyes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can

product that can produce serious adverse effects if a child or pet chews or ingests this patch.

S

STOP USE

Stop use and ask 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

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poision Control Center right away.

INDICATIONS & USAGE

Directions

adults and children over 12 years:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing seperates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• use 1 patch for up to 12 hours

INACTIVE INGREDIENT

Inactive ingredients aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, silicon dioxide, sodium polyacrylate, tartaric acid, titanium dioxide, urea, waterDistributed by

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 U.S.A.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE LIDOCAINE PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	560 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-159-01	1 in 1 POUCH; Type 0: Not a Combination Product	01/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/23/2017

Labeler - United Exchange Corp. (840130579)