CORALITE PAIN RELIEF STICK- menthol, and methyl salicylate stick 
United Exchange Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients                                                           Purpose

Methol 4%.......................................................Topical analgesic

Methyl salicylate 1%.........................................Topical analgesic

Uses

For temporary relief of minor muscle and joint discomfort associated with:

Warnings

For external use only. If pregnant or breast-feeding, ask a health professional before use.

Allergy Alert: Do not use if allergic to salicylates (including aspirin) without consulting a physician.

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 and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present or irritation develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and Children 10 Years of Age and Older

Childreun Under 10 Years of Age Consult a doctor

Other information

Inactive ingredients ethyl alcohol, hydrogenated castor oil, PEG-150 distearate, propylene glycol, sodium stearate, water

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

www.ueccorp.com

Toll Free: 1 800 814 8028

Made in China

image description

CORALITE PAIN RELIEF STICK 
menthol, and methyl salicylate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYL ALCOHOL (UNII: Y4S76JWI15)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-120-0157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/10/2016
Labeler - United Exchange Corp. (840130579)

Revised: 2/2016
Document Id: 7903a819-9037-47b8-a04b-c04aa9b64c49
Set id: 3e87cd68-095a-4d0d-8c25-7256f1954d73
Version: 1
Effective Time: 20160210
 
United Exchange Corp.