Label: AY BENDITO - THERMOACTIVE- camphor, menthol cream
- NDC Code(s): 72524-641-04
- 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 October 18, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
- PREGNANCY OR BREAST FEEDING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
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.
Aqua, Alcohol Denat, Glycerin, Paraffinum Liquidum, Triethanolamine, Arnica Montana Flower Extract, Polysorbate 20, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue.1 Powder (CI 42090).
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
AY BENDITO - THERMOACTIVE
camphor, menthol cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72524-641 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 6 g in 100 g MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)- 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 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) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72524-641-04 113 g in 1 TUBE; 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(72524-641)