NDC 76305-300-06
API & Excipient Details

marketed by China-Gel, LLC under NDC Code 76305-300-06

NDC Code(s) : 76305-300-02, 76305-300-03, 76305-300-04, 76305-300-05, 76305-300-06, 76305-300-07, 76305-300-13
Packager : China-Gel, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

China-Gel Menthol and Camohor (synthetic) CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76305-300
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL(UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg in 1 g
CAMPHOR (SYNTHETIC)(UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
WATER(UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA LEAF(UNII: T07U1161SV)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
TROLAMINE(UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYSORBATE 60(UNII: CAL22UVI4M)
LAVANDIN OIL(UNII: 9RES347CKG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76305-300-02	113.5 g in 1 JAR Type 0: Not a Combination Product	19/08/2000
2	NDC:76305-300-03	170 g in 1 TUBE Type 0: Not a Combination Product	19/08/2000
3	NDC:76305-300-04	226.8 g in 1 JAR Type 0: Not a Combination Product	19/08/2000
4	NDC:76305-300-05	453.6 g in 1 JAR Type 0: Not a Combination Product	19/08/2000
5	NDC:76305-300-06	3628.7 g in 1 JUG Type 0: Not a Combination Product	19/08/2000
6	NDC:76305-300-07	199578.5 g in 1 DRUM Type 0: Not a Combination Product	19/08/2000
7	NDC:76305-300-13	56.8 g in 1 TUBE Type 0: Not a Combination Product	19/08/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	08/19/2000

LABELER - China-Gel, LLC(941374068)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL