CORALITE ODOR FREE PAIN RELIEF- lidocaine patch

Coralite Odor Free Pain Relief by

Drug Labeling and Warnings

Coralite Odor Free Pain Relief by is a Otc medication manufactured, distributed, or labeled by United Exchange Corporation. 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
• at the same time as other topical analgesics
• 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 warning on this label.
• do not allow contact with the eyes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower
• dispose of used patch in manner that always keeps product away from children or 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

Stop use and ask a doctor if

• condition worsens
• redness is present
• symptoms persist for more than 7 days or clear up and occur again within a few days
• irritation develops
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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
• children 12 years or younger: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

QUESTIONS

Questions or comments?

Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)

DOSAGE & ADMINISTRATION

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE ODOR FREE PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALCOHOL (UNII: 3K9958V90M)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-149-01	1 in 1 POUCH	10/29/2018
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/29/2018

Labeler - United Exchange Corporation (840130579)