AY BENDITO THERMOACTIVE

Manufacturer
AY BENDITO INTERNATIONAL, INC
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:54

Label at a glance#

ProductAY BENDITO THERMOACTIVE
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure10 sections

Dosage and administration

Adults and Children over 12 years of age Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily. Children under 12 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 6%

Menthol 4%

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of minor pains on muscles or joints.

WARNINGS SECTION

For external use only.

Do not apply to wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Flammable

SAFE HANDLING WARNING SECTION

Keep away from fire or flame.

OTC - WHEN USING SECTION

Use only as directed.
Do not bandage tightly.
Avoid contact with eyes and mucous membranes.
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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 of 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

Keep out of reach of children

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years of age

Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Alcohol Denat, Water (Aqua), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Benzyl Alcohol, Sorbic Acid, Salicylic Acid.

OTC - QUESTIONS SECTION

Call +1-787-421-6423

AY BENDITO THERMOACTIVE SPRAY 2 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AY BENDITO 2AY BENDITO 2

AY BENDITO THERMOACTIVE SPRAY 4 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AY BENDITO 4AY BENDITO 4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72524-046-02AY BENDITO THERMOACTIVE59 mL in 1 BOTTLE, SPRAYSPRAY591
72524-046-04AY BENDITO THERMOACTIVE118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72524-046AY BENDITO THERMOACTIVE (MENTHOL, CAMPHOR) SPRAY [AY BENDITO INTERNATIONAL, INC]1Current NDC, 2 package rows20250328_304d71b6-91c8-b2b6-e063-6394a90ab669.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72524-04672524-046-02, 72524-046-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
ndc (package): 72524-046-04
ndc (package): 72524-046-02
ndc (product): 72524-046
ndc11 (package): 72524004604
ndc11 (package): 72524004602
spl id: 304d71b6-91c9-b2b6-e063-6394a90ab669
spl set id: 304d71b6-91c8-b2b6-e063-6394a90ab669

Reported adverse events (FAERS/openFDA)#

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