CORALITE BLUE ICE- menthol gel

Coralite Blue Ice by

Drug Labeling and Warnings

Coralite Blue Ice 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 2%........................................................Topical analgesic   

PURPOSE

Uses

• temporarily relieves minor aches and pains of muscles and joints associated with:
• arthritis
• simple backache 
• strains
• bruises
• sport injuries
• sprains
• provides cooling penetrating relief

WARNINGS

Warnings 

For external use only

DO NOT USE

Do not use

• with other topical pain relievers
• with heating pads or heating devices

WHEN USING

When using this product

• do not use in or near the eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• redness or 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

• Clean affected area before applying product
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store in a cool place
• keep lid tightly closed
• do not use, pour, spill or store near heat or open flame

INACTIVE INGREDIENT

Inactive ingredients

ammonium hydroxide, carbomer 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate heptahydrate, purified water, sodium hydroxide, thymol

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 U.S.A.

www.ueccorp.com

Toll Free: 1 800 814 8028

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE BLUE ICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARBOMER 940 (UNII: 4Q93RCW27E)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-157-27	227 g in 1 JAR; Type 0: Not a Combination Product	10/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/05/2016

Labeler - United Exchange Corp. (840130579)