LABOFLEX Cool & Hot Patch

Manufacturer
Laboflex, Inc. | WOOSHIN LAPACHE d.o.o.
Effective date
2023-09-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:26:17

Label at a glance#

ProductLABOFLEX Cool and Hot Menthol 1.25 percent Capsaicin 0.025 percent
Active ingredientMENTHOL, CAPSAICIN
Label structure13 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Capsicum extract 0.025% as Capsaicin

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Questions or Comments

OTC - QUESTIONS SECTION

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

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83655-10383655-103-11, 83655-103-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28548ea2-7eab-9a69-e063-6394a90a228e04cd5d12-0dd6-5cd5-e063-6294a90a17bc2024-12-02WarningsExact identifier
spl set id: 04cd5d12-0dd6-5cd5-e063-6294a90a17bc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.