CORALITE COLD AND HOT- menthol patch

Coralite Cold and Hot by

Drug Labeling and Warnings

Coralite Cold and Hot 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

Menthol 5%......................................... Topical analgesic

PURPOSE

Uses

Temporarily relieves minor aches and pains of muscles and joint due to:

• arthritis
• simple backache
• muscle strains
• bursitis
• tendonitis
• muscle sprains
• 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 doctof if:

• conditions worsens
• symptoms persist for 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 Contro Center right away.

INDICATIONS & USAGE

Directions

Adults and children 12 years of age and older

• peel off protective backing and apply sticky side to affected area
• carefully remove backing from patch
• should be used up to 8 hours
• should be used no more than 3 hours a day
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

store at room temperature, not to exceed 86°F (30°C)

INACTIVE INGREDIENT

Inactive Ingredients

alove 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, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate 

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE COLD AND HOT 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 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 ACETATE (UNII: 80EHD8I43D)
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: 65923-151-01	1 in 1 POUCH	07/13/2017
1		5 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)