CORALITE MEDICATED HEAT- capsaicin patch

Coralite Medicated Heat by

Drug Labeling and Warnings

Coralite Medicated Heat 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

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

PURPOSE

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

• Simple Backache
• Arthritis
• Strains
• Bruises
• Sprains

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
• if prone to allergic reaction from aspirin or salicylates, consult a doctor before use

DO NOT USE

Do not use:

• on wounds or damaged skin.
• with a heating pad.

WHEN USING

When using this product:

• do not use otherwise than 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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and older:
• clean and dry affected area
• remove patch from film
• apply to affected area no more than 3 to 4 times daily
• do not wear patch more than 8 hours
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• Avoid storing product in direct sunlight.
• Protect product from excessive moisture.

INACTIVE INGREDIENT

Inactive ingredients

lanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

Made in China

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE MEDICATED HEAT 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	249 mg

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
METHYL SALICYLATE (UNII: LAV5U5022Y)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
ROSIN (UNII: 88S87KL877)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-123-01	1 in 1 POUCH	10/30/2018
1		249 in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 65923-123-02	2 in 1 POUCH	02/10/2016
2		249 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	02/10/2016

Labeler - United Exchange Corp. (840130579)