CORALITE PAIN RELIEF HOT- menthol and capsaicin patch

Coralite Pain Relief Hot by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient Purpose

Capsicum extract 0.083% as Capsaicin........Topical analgesic

Menthol 3%....................................................Topical analgesic

PURPOSE

Uses

temporarily relieves minor pain of muscles and joints associated with:

• arthritis
• simple backache
• strains
• sprains
• bruises

WARNINGS

Warnings

For external use only

Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad

WHEN USING

When using this product

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

STOP USE

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present or irritation or rash develops
• a severe burning sensation occurs

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 18 years of age and older:
• clean and dry affected area
• remove patch from film
• apply to affected area not more than 3 to 4 times daily
• removed patch from the skin after 8 hours application
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• avoid storing product in direct sunlight
• protect product from excessive moisture

INACTIVE INGREDIENT

Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, 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 PAIN RELIEF HOT 
menthol and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.83 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
TARTARIC ACID (UNII: W4888I119H)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-146-02	2 in 1 POUCH	10/23/2018
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	10/23/2018

Labeler - United Exchange Corporation (840130579)