Label: AY BENDITO - THERMOACTIVE- camphor, menthol gel
- NDC Code(s): 72524-604-04
- Packager: AY BENDITO INTERNATIONAL, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 25, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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 physicianDo not expose the area treated with product to heat or direct sunlight.
- STOP USE
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
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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?
- AY BENDITO THERMOACTIVE GEL
-
INGREDIENTS AND APPEARANCE
AY BENDITO - THERMOACTIVE
camphor, menthol gelProduct 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)