AY BENDITO - THERMOACTIVE

Manufacturer
AY BENDITO INTERNATIONAL, INC
Effective date
2025-04-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:59:10

Label at a glance#

ProductAY BENDITO - THERMOACTIVE
Active ingredientCAMPHOR (NATURAL), MENTHOL, (+)-
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor ………………. 6%

Menthol …………….…. 4%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

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, broken or irritated skin
A transient burning sensation or redness may occur upon application but generally disappears in several days
If you experience an allergic reaction, discontinue use and consult a doctor

Do not expose the area treated with product to heat or direct sunlight.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF:

Condition worsens
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up occur again within a few days
You experience signs injury, such as pain, swelling or blistering where the product was applied.

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years of age

Apply a small amount on the affected area.

Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Triethanolamine, Arnica Montana Flower Extract, Polysorbate 20, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).

QUESTION OR COMMENTS?

OTC - QUESTIONS SECTION

Call: +1-787-421-6423

AY BENDITO THERMOACTIVE CREAM TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AY BENDITO TC TUBEAY BENDITO TC TUBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2610198camphor 6 % / menthol 4 % Topical CreamPSN9
2610198camphor 60 MG/ML / menthol 40 MG/ML Topical CreamSCD9
2610198camphor 6 % / menthol 4 % Topical CreamSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72524-641-04AY BENDITO - THERMOACTIVE113 g in 1 TUBECREAM1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72524-641AY BENDITO - THERMOACTIVE (CAMPHOR, MENTHOL) CREAM [AY BENDITO INTERNATIONAL, INC]9Current NDC, Legacy NDC, 1 package rows20250416_bbf0d85e-269d-0342-e053-2995a90ac63c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72524-64172524-641-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0d85e-269d-0342-e053-2995a90ac63c2025-04-14WarningsExact identifier
ndc (package): 72524-641-04
ndc (product): 72524-641
ndc11 (package): 72524064104
spl id: 32c5f87f-17cb-c554-e063-6394a90a1257
spl set id: bbf0d85e-269d-0342-e053-2995a90ac63c

Reported adverse events (FAERS/openFDA)#

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