NDC Code(s) : 55319-111-01
Packager : Family Dollar

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Maximum Strength Feminine Anti-Itch Benzocaine 20.00% Resorcinol 3.00% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55319-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		Benzocaine20 g in 100 g
RESORCINOL(UNII: YUL4LO94HK)
(RESORCINOL - UNII:YUL4LO94HK) 		RESORCINOL3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Mineral Oil(UNII: T5L8T28FGP)
Cetyl Alcohol(UNII: 936JST6JCN)
Propylene Glycol(UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 Stearate(UNII: YD01N1999R)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
ALOE(UNII: V5VD430YW9)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CORN OIL(UNII: 8470G57WFM)
Cholecalciferol(UNII: 1C6V77QF41)
LANOLIN ALCOHOLS(UNII: 884C3FA9HE)
Methylparaben(UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: HHT01ZNK31)
Isopropyl Myristate(UNII: 0RE8K4LNJS)
Isopropyl Stearate(UNII: 43253ZW1MZ)
Sodium Sulfite(UNII: VTK01UQK3G)
TROLAMINE(UNII: 9O3K93S3TK)
Trisodium HEDTA(UNII: K3E0U7O8KI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55319-111-011 in 1 CARTON 28/11/2014
128 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/28/2014

PRINCIPAL DISPLAY PANEL

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