NDC Code(s) : 11509-0360-1, 11509-0360-2, 11509-0372-1
Packager : Combe Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vagisil Anti Itch Original StrengthBenzocaine and Resorcinol CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11509-0360
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE50 mg in 1 g
RESORCINOL(UNII: YUL4LO94HK)
(RESORCINOL - UNII:YUL4LO94HK) 		RESORCINOL20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
MINERAL OIL(UNII: T5L8T28FGP)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
CORN OIL(UNII: 8470G57WFM)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
METHYLPARABEN(UNII: A2I8C7HI9T)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SODIUM SULFITE(UNII: VTK01UQK3G)
TROLAMINE(UNII: 9O3K93S3TK)
TRISODIUM HEDTA(UNII: K3E0U7O8KI)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11509-0360-11 in 1 CARTON
128 g in 1 TUBE
2NDC:11509-0360-21 in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 08/01/1974
Vagisil Anti Itch Maximum StrengthBenzocaine and Resorcinol CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11509-0372
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE200 mg in 1 g
RESORCINOL(UNII: YUL4LO94HK)
(RESORCINOL - UNII:YUL4LO94HK) 		RESORCINOL30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
MINERAL OIL(UNII: T5L8T28FGP)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
CORN OIL(UNII: 8470G57WFM)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
METHYLPARABEN(UNII: A2I8C7HI9T)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SODIUM SULFITE(UNII: VTK01UQK3G)
TROLAMINE(UNII: 9O3K93S3TK)
TRISODIUM HEDTA(UNII: K3E0U7O8KI)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11509-0372-11 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 08/01/1974

PRINCIPAL DISPLAY PANEL

Vagisil®

ANTI-ITCH CREME

ORIGINAL STRENGTH       NET WT. 1 OZ (28 g)

Principal Display Panel - Original Strength 1oz

PRINCIPAL DISPLAY PANEL

Vagisil®

ANTI-ITCH CREME

MAXIMUM STRENGTH       NET WT. 1 OZ (28 g)

Principal Display Panel - Maximum Strength 1oz