49283-541-03

MENTHOL, LIDOCAINE, CAMPHOR- menthol, lidocaine, camphor gel
CHEMCO CORPORATION

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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MENTHOL, LIDOCAINE, CAMPHOR
menthol, lidocaine, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49283-541
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	11 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER 940 (UNII: 4Q93RCW27E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYL SALICYLATE (UNII: LAV5U5022Y)
BASIC BLUE 1 (UNII: 92N74OA24D)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49283-541-03	90 g in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	07/27/2021

Labeler - CHEMCO CORPORATION (032495954)

Registrant - CHEMCO CORPORATION (032495954)

Name	Address	ID/FEI	Business Operations
Establishment
CHEMCO CORPORATION		032495954	manufacture(49283-541)