FDA Label for Ay Bendito - Thermoactive
View Indications, Usage & Precautions
Ay Bendito - Thermoactive Product Label
The following document was submitted to the FDA by the labeler of this product Ay Bendito - Thermoactive Lotion. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Camphor ………………. 6%
Menthol …….…………. 4.05%
Otc - Purpose
Analgesic
Indications & Usage
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
Otc - When Using
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 physician
Do not expose the area treated with product to heat or direct sunlight.
Other Safety Information
FLAMMABLE:
Keep away from fire or flame.
Otc - Pregnancy Or Breast Feeding
IF PREGNANT OR BREAST – FEEDING:
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
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.
Dosage & Administration
DIRECTIONS:
Adults and Children over 12 years:
Apply a small amount on the area to be.
Massaged in a circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Processed under the highest standards of quality assurance and Good Manufacturing Practices.
Inactive Ingredient
Aqua, Alcohol Denat, Glycerin, Paraffinum Liquidum, Arnica Montana Flower Extract, Triethanolamine, Carbomer, Methyl Salicylate, Glucosamine Sulfate, Sodium Chondroitin Sulfate, Rosmarinus Officinalis (Rosemary) Extract, FD&C Blue #1 Powder (CI 42090), Methylchloroisothiazolinone, Methylisothiazolinone.
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