Label: AY BENDITO - CBD- camphor, menthol gel
- NDC Code(s): 72524-009-04, 72524-009-17
- 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 September 6, 2023
If you are a consumer or patient please visit this version.
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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 doctorDo not expose the area treated with product to heat or direct sunlight.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
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INACTIVE INGREDIENT
Water (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 No.1 (CI 42090).
- QUESTION OR COMMENTS?
- AY BENDITO - CBD ROLL ON
- AY BENDITO - CBD SACHET
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INGREDIENTS AND APPEARANCE
AY BENDITO - CBD
camphor, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72524-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 6 g in 100 g Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYL SALICYLATE (UNII: LAV5U5022Y) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) CARBOMER 940 (UNII: 4Q93RCW27E) MINERAL OIL (UNII: T5L8T28FGP) ALCOHOL (UNII: 3K9958V90M) CANNABIDIOL (UNII: 19GBJ60SN5) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) Product Characteristics Color green (Light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72524-009-04 90.15 g in 1 BOTTLE; Type 0: Not a Combination Product 09/08/2023 2 NDC:72524-009-17 5 g in 1 PACKET; Type 0: Not a Combination Product 09/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/08/2023 Labeler - AY BENDITO INTERNATIONAL, INC (081332094)