AY BENDITO - THERMOACTIVE- camphor, menthol gel

AY BENDITO - THERMOACTIVE by

Drug Labeling and Warnings

AY BENDITO - THERMOACTIVE by is a Otc medication manufactured, distributed, or labeled by AY BENDITO INTERNATIONAL, INC, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor ………………. 6%

Menthol …….…………. 4%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only.

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.

STOP USE

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.

PREGNANCY

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDEN:

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

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Arnica Montana Flower Extract, Triethanolamine, 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?

Call: +1-787-421-6423

AY BENDITO THERMOACTIVE GEL

INGREDIENTS AND APPEARANCE

AY BENDITO - THERMOACTIVE 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72524-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W)	MENTHOL, (+)-	4 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72524-604-04	90 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/22/2021

Labeler - AY BENDITO INTERNATIONAL, INC (081332094)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(72524-604)