CORALITE PAIN RELIEF- menthol capsaicin 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

Menthol 30 mg................................................ Topical analgesic

Capsaicin 8.3 mg............................................. Topical analgesic

PURPOSE

Uses

Temporarily relieves minor pain associated with:

• arthritis
• simple backache
• bursitis
• tendonitis
• muscle strains
• bruises
• cramps

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged skin

STOP USE

Stop use and ask a doctor if:

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

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 right away.

INDICATIONS & USAGE

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• Children under 12 year of age: do not use, consult a doctor
• For easy applications: partially peel back protectice film and apply exposed patch to site of pain.
• Carefully remove remaining film while pressing patch to skin for secure adhesion.

INACTIVE INGREDIENT

Inactive ingredients

aloe vera gel, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate,

kaolin, magnesium aluminosilicate, methylparaben, PEG monostearate, polysorbate 80, polyvinyl alcohol, purifed water, PVP, sodium

polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHNAGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE PAIN RELIEF 
menthol capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-152
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	8.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
ALMASILATE (UNII: OZQ8O62H53)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-152-02	2 in 1 POUCH	07/13/2017
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	12/12/2013

Labeler - United Exchange Corp. (840130579)