49283-331-04

CAMPHOR- 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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CAMPHOR
camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49283-331
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	94.8 mL in 99 mL

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
WATER (UNII: 059QF0KO0R)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
OLETH-20 (UNII: YTH167I2AG)
MENTHOL (UNII: L7T10EIP3A)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DIPROPYLENE GLYCOL MONOCAPRATE MONOCAPRYLATE (UNII: 5980W979EL)
METHYLPARABEN (UNII: A2I8C7HI9T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49283-331-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
2	NDC:49283-331-05	18927 mL in 1 PAIL; Type 0: Not a Combination Product	06/23/2020
3	NDC:49283-331-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/11/2020

Labeler - Chemco Corporation (032495954)

Registrant - Chemco Corporation (032495954)

Name	Address	ID/FEI	Business Operations
Establishment
Chemco Corporation		032495954	manufacture(49283-331)