72524-641-04

CAMPHOR, MENTHOL- 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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CAMPHOR, MENTHOL
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72524-641
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72524-641-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2021

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

Labeler - AY BENDITO INTERNATIONAL, INC (081332094)

Registrant - CHEMCO CORPORATION (032495954)

Name	Address	ID/FEI	Business Operations
Establishment
CHEMCO CORPORATION		032495954	manufacture(72524-641)