AY BENDITO - CBD- camphor, menthol gel 
AY BENDITO INTERNATIONAL, INC

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.

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72524-009-04
72524-009-17

Camphor ………………. 6%

Menthol …………….…. 4%

Topical Analgesic

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

For external use only.

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 doctor

Do not expose the area treated with product to heat or direct sunlight.

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.

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

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

DIRECTIONS:

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).

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?

Call: +1-787-421-6423

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AY BENDITO - CBD 
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72524-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (Light) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72524-009-0490.15 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2023
2NDC:72524-009-175 g in 1 PACKET; Type 0: Not a Combination Product09/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/08/2023
Labeler - AY BENDITO INTERNATIONAL, INC (081332094)

Revised: 9/2023
Document Id: 04b1d0b2-0b28-72c9-e063-6294a90a0c26
Set id: 04b1d605-60aa-56f4-e063-6294a90ae760
Version: 1
Effective Time: 20230906
 
AY BENDITO INTERNATIONAL, INC