CORALITE PAIN RELIEF- camphor, menthol, methyl salicylate patch

Coralite Pain Relief by

Drug Labeling and Warnings

Coralite 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 ingredients Purpose

Camphor 1.2%........................................Topical Analgesic

Menthol 5.7%..........................................Topical Analgesic

Methyl Salicylate 6.3%............................Topical Analgesic

PURPOSE

Uses

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

• arthritis
• simple backache
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only

Allergy alert: 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
• if you are allergic to any ingredients of this product
• on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

Ask a doctor before use if you have redness over the affected area.

WHEN USING

When using this product

• do not use other 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

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

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 conduct a Poision Control Center right away

INDICATIONS & USAGE

Directions

adults and children 12 years of age and over:

• clean and dry affected area
• remove patch from film
• apply to affected area not more than 3 to 4 times daily
• do not wear patch for more than 4 hours
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

glyceryl rosinate, lanolin, natural latex rubber, petrolatum, polyisobutylene, zinc oxide

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE PAIN RELIEF 
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-564
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.7 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	6.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)
GLYCERYL ROSINATE (UNII: SD112V492J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-564-20	20 in 1 PACKAGE	04/12/2018
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	04/12/2016

Labeler - United Exchange Corp. (840130579)