CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE KNEE- menthol patch

Coralite Extra Strength Pain Relief Sleeve Knee by

Drug Labeling and Warnings

Coralite Extra Strength Pain Relief Sleeve Knee 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 16.0%..................................................Topical Analgesic Patch

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• on wounds or damaged skin
• 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

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly over sleeve or use with a heating pad
• 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

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• redness is present or irritation or rash 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 (1-800-222-1222) right away

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and older:
• open pouch and remove sleeve
• remove plastic insert and discard
• pull sleeve onto knee, large ankles or elbows until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this.
• apply one sleeve to affected area no more than 3 times daily
• do not wear sleeve for more than 8 hours
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inative ingredients

carbomer 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE KNEE 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	336 mg

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ETHYLPARABEN (UNII: 14255EXE39)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-121-01	1 in 1 BOX	02/10/2016
1		1 in 1 POUCH; 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	02/10/2016

Labeler - United Exchange Corp. (840130579)