AY BENDITO - THERMOACTIVE
- Manufacturer
- AY BENDITO - THERMOACTIVE LOTION
- Effective date
- 2025-05-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:15
Label at a glance#
Contacts and useful links#
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
DIRECTIONS:
Adults and Children over 12 years:
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
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, Arnica Montana Flower Extract, Triethanolamine, Carbomer, Methyl Salicylate, Glucosamine Sulfate, Sodium Chondroitin Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).
QUESTION OR COMMENTS?
Call: +1-787-421-6423
AY BENDITO THERMOACTIVE LOTION SACHET
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72524-005-06 | 2022-08-31 | C162847 | 48780-1 | ba0f9c33-4e4d-a910-e053-dadaa90a0b85 | 72524-005-06 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72524-005-06 | AY BENDITO - THERMOACTIVE | 5 g in 1 PACKET | LOTION | 5 | 9 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- AY BENDITO - THERMOACTIVE
- Camphor, Menthol
- POLYSORBATE 20
- ROSMARINUS OFFICINALIS WHOLE
- SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)
- ARNICA MONTANA FLOWER
- FD&C BLUE NO. 1
- CARBOMER 940
- ALCOHOL
- MINERAL OIL
- CAMPHOR (NATURAL)
- MENTHOL
- GLYCERIN
- TROLAMINE
- METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE
- METHYL SALICYLATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72524-005 | 72524-005-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AY BENDITO - THERMOACTIVE | CAMPHOR, MENTHOL | AY BENDITO - THERMOACTIVE LOTION | 835abc66-680f-be06-e053-2a91aa0a309e | 2025-05-19 | Warnings | 72524-005-06 72524-005 72524000506 3585de8a-7d59-e4e6-e063-6394a90a34b9 835abc66-680f-be06-e053-2a91aa0a309e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
