CORALITE MUSCLE AND JOINT PAIN RELIEF- camphor, menthol, and mehtyl salicylate patch

Coralite Muscle and Joint Pain Relief by

Drug Labeling and Warnings

Coralite Muscle and Joint 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 Ingredients Purposes

Camphor 1.2%...................Topical analgesic

Menthol 5.7%.....................Topical analgesic

Methyl salicylate 6.3%.......Topical analgesic

PURPOSE

Uses

• temporarily relieves the minor aches and pains of muscles and joints associated with:
• sprains
• simple backache
• arthritis
• strains
• bruises

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 otherwise than as directed
• avoid contact with 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
• conditioin 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 contact a Poison Control Center (1-800-222-1222) right away.

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 for more than 4 hours
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

• store at room temperature 20-25°C (68-77ºF)
• avoid storing product in direct sunlight
• protect product from excessive moisture

INACTIVE INGREDIENT

Inactive ingredients

aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin, polyisobutylene (80000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

QUESTIONS

Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

DOSAGE & ADMINISTRATION

Distributed By:

UNITED EXCHANGE CORP.

Cypress, CA. 90630 USA

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE MUSCLE AND JOINT PAIN RELIEF 
camphor, menthol, and mehtyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	12 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	57 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	63 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
PARAFFIN (UNII: I9O0E3H2ZE)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
GLYCERYL ROSINATE (UNII: SD112V492J)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LANOLIN (UNII: 7EV65EAW6H)
POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-163-02	1 in 1 POUCH	01/13/2023
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	01/13/2023

Labeler - United Exchange Corporation (840130579)