LABOFLEX COOL AND HOT MENTHOL 1.25 PERCENT CAPSAICIN 0.025 PERCENT- menthol, capsaicin patch 
WOOSHIN LABOTTACH 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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LaboFlex Cool & Hot Patch

ACTIVE INGREDIENTS

Menthol 1.25%

Capsicum extract 0.025% as Capsaicin

INACTIVE INGREDIENTS

Aluminum Glycinate, Butylhydroxytoluene(BHT), Carboxymethylcellulose Sodium, Glycerin, Disodium EDTA, Kaolin, Polysorbate 80, Povidone-K90, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water

PURPOSE

Topical Analgesic

WARNINGS

For external use only

Do not use ■ On wounds or damaged skin ■ With a heating pad ■ If you are allergic to any ingredients of this product.

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

Uses

For temporary relief of minor aches and pains of muscles and joints associated with ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains

Directions

Adult and children 12 years of age and over :

■ Clean and dry affected area ■ Remove film from patch and apply to the skin ■ Apply to affected area not more than 3 to 4 times daily ■ Remove patch from the skin after at most 8-hour application.

Children under 12 years of age : Consult a doctor

Other Information

■ Avoid storing product in direct sunlight ■ Protect product from excessive moisture

Questions or Comments

Questions or comments? Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

When using this product

When using this product ■ Use only as directed ■ Avoid contact with the eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Discontinue use at least 1 hour before a bath or shower ■ Do not use immediately after a bath or shower.

Stop use and ask a doctor if

Stop use and ask a doctor if ■ Skin reactions such as redness, itching, rash excessive irritation, burning sensation, swelling or blistering occur ■ Condition worsen ■ Symptoms persist for more than 7 days ■

Symptoms clear up and occur again within a few days.

If pregnant or breast-feeding

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonLabel

LABOFLEX COOL AND HOT MENTHOL 1.25 PERCENT CAPSAICIN 0.025 PERCENT 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82957-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL87.5 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.75 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82957-103-112 in 1 CARTON02/20/2023
15 in 1 POUCH; Type 0: Not a Combination Product
2NDC:82957-103-125 in 1 POUCH; Type 0: Not a Combination Product02/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/20/2023
Labeler - WOOSHIN LABOTTACH CO., LTD. (688269808)
Registrant - WOOSHIN LABOTTACH CO., LTD. (688269808)
Establishment
NameAddressID/FEIBusiness Operations
WOOSHIN LAPACHE d.o.o.507385209manufacture(82957-103)

Revised: 3/2023
Document Id: f6d59e7e-3fbc-d9f8-e053-6394a90a7095
Set id: f530652f-989b-90f4-e053-2a95a90a9907
Version: 3
Effective Time: 20230314
 
WOOSHIN LABOTTACH CO., LTD.