CORALITE TOPICAL ANALGESIC CAPSAICIN HEAT- capsaicin liquid 
Shanghai Aquagel Bio-polymer Co., Ltd

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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Coralite Topical Analgesic Capsaicin Heat Patch

Active ingredient                                                 Purpose
Capsicum Extract Capsaicin 0.025%....................Topical Analgesic

 Purpose

Topical Analgesic

Uses  For temporary relief of minor aches and pains of muscles and joints associated with: - Simple Backache - Arthritis - Strains - Bruises - Sprains

Warnings For external use only Discontinue use at least one hour before a shower or bath and do not use immediately after a shower or bath

Do not use: - on wounds or damaged skin.
- with a heating pad.
- with, or at the same times as, other external analgesic products.
- if you are allergic to any ingredients of this product.

When using this product: - do not use otherwise than as directed.
- avoid contact with the eyes, mucous membrances or rashes.

stop use and ask a doctor if: - rash itching or excessive skin irritation develops.
- conditions worsen.
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days.

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

Directions Adults and Children 12 years of age and over:
- Clean and dry affected area.
- Remove patch from film.
- Apply to affected area not more than 3 to 4 times daily for 7 days.
- Remove patch from skin after at most 8 hours of application.

Children Under 12 Years of Age: Consult a physician.

Other information - Avoid storing product in direct sunlight.
- Protect product from excessive mositure.


Inactive ingredients: belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl salicylate, polyester resin, zinc oxide

Coralite                                 CAPSAICIN HEAT PATCH

TEAR OPEN HERE               TOPICAL ANALGESIC

This product is not manufactured or distributed by Hisamitsu, owner of Solonpas - Hot Capsicum Patch

Distributed by: C URC

UNITED EXCHANGE CORP.
17211 Valley View Ave.
Cerritos, CA 90703 USA
MADE IN CHINA

Lot:

Exp:

40   210mm


Compare to the active ingredient in Salonpas - Hot Capsicum Patch

Coralite

TOPICAL ANALGESIC

CAPSAICIN HEAT PATCH

Temporary Relief of Minor Aches and Pains of Muscles and Joints Associated with:

Arthritis  Backaches  Bruises  Strains  Sprains

MEDICATED HEAT PATCH 1 patch

5.12 IN x 7.09 IN (13 CM x 18 CM)

Distributed by: C URC

UNITED EXCHANGE CORP.
17211 Valley View Ave.
Cerritos, CA 90703 USA
MADE IN CHINA

Lot:

Exp:

Coralite                        TOPICAL ANALGESIC

CAPSAICIN HEAT PATCH

Coralite                        TOPICAL ANALGESIC

CAPSAICIN HEAT PATCH

1 Patch 5.12 IN x 7.09 IN

Coralite                        TOPICAL ANALGESIC

CAPSAICIN HEAT PATCH

Compare to the active ingredient in Salonpas - Hot Capsicum Patch

Coralite

TOPICAL ANALGESIC

CAPSAICIN HEAT PATCH

Temporary Relief of Minor Aches and Pains of Muscles and Joints Associated with:

Arthritis  Backaches  Bruises  Strains  Sprains

MEDICATED HEAT PATCH 1 patch

5.12 IN x 7.09 IN

Coralite                        TOPICAL ANALGESIC

CAPSAICIN HEAT PATCH

Capsaicin Heat Patch

Capsaicin Heat Patch Outer Box

CORALITE TOPICAL ANALGESIC CAPSAICIN HEAT 
capsaicin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52755-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BELLADONNA LEAF (UNII: 6GZW20TIOI)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
LANOLIN (UNII: 7EV65EAW6H)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PETROLATUM (UNII: 4T6H12BN9U)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52755-300-001 in 1 PACKAGE
1135 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/07/201011/11/2015
Labeler - Shanghai Aquagel Bio-polymer Co., Ltd (421199544)

Revised: 11/2015
 
Shanghai Aquagel Bio-polymer Co., Ltd