NDC Code(s) : 68229-300-01, 68229-300-02, 68229-300-03, 68229-300-04
Packager : Quest Products, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alocane PlusLidocaine Hydrochloride and Benzalkonium Chloride GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68229-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE4 g in 100 mL
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPANEDIOL(UNII: 5965N8W85T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
DIMETHYL ISOSORBIDE(UNII: SA6A6V432S)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)(UNII: M825OX60H9)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CHLORPHENESIN(UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68229-300-0250 in 1 BOX 12/11/2013
1NDC:68229-300-013.55 mL in 1 DOSE PACK Type 0: Not a Combination Product
2NDC:68229-300-031 in 1 CARTON 03/01/2020
259 mL in 1 TUBE Type 0: Not a Combination Product
3NDC:68229-300-04946 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product07/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 12/11/2013

LABELER - Quest Products, Inc.(075402441)

Establishment
Name Address ID/FEI Business Operations
Fill Tech USA 926433855 manufacture(68229-300)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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