NDC Code(s) : 68229-201-01, 68229-201-02, 68229-201-03, 68229-201-04, 68229-201-05, 68229-201-06, 68229-201-07, 68229-201-08, 68229-201-11, 68229-201-09, 68229-201-10, 68229-201-14, 68229-201-15, 68229-201-12, 68229-201-13, 68229-201-17, 68229-201-18, 68229-201-16
Packager : Quest Products, LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alocane Emergency BurnLidocaine Hydrochloride GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68229-201
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
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:68229-201-021 in 1 CARTON 03/01/2019
1NDC:68229-201-01110 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:68229-201-03110 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product03/01/2020
3NDC:68229-201-0524 in 1 CARTON 03/01/2020
3NDC:68229-201-043.4 mL in 1 PACKET Type 0: Not a Combination Product03/01/2020
4NDC:68229-201-0745 in 1 CARTON 03/01/2020
4NDC:68229-201-063.4 mL in 1 PACKET Type 0: Not a Combination Product03/01/2020
5NDC:68229-201-08103.507 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product03/01/2020
6NDC:68229-201-11133.081 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product03/01/2020
7NDC:68229-201-101 in 1 CARTON 03/01/2019
7NDC:68229-201-09118.294 mL in 1 TUBE Type 0: Not a Combination Product03/01/2020
8NDC:68229-201-14946 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product03/01/2019
9NDC:68229-201-121 in 1 KIT 03/01/2019
9NDC:68229-201-15800 mL in 1 BAG Type 0: Not a Combination Product03/01/2019
10NDC:68229-201-131 in 1 CARTON 03/01/2019
10NDC:68229-201-15800 mL in 1 BAG Type 0: Not a Combination Product03/01/2019
11NDC:68229-201-181 in 1 CARTON 12/09/2021
11NDC:68229-201-1722 mL in 1 TUBE Type 0: Not a Combination Product03/01/2019
12NDC:68229-201-16124 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product11/11/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 03/01/2019

LABELER - Quest Products, LLC.(075402441)

Establishment
Name Address ID/FEI Business Operations
Fill Tech USA 926433855 manufacture(68229-201)

PRINCIPAL DISPLAY PANEL

201-02

PRINCIPAL DISPLAY PANEL

201-14

PRINCIPAL DISPLAY PANEL

45SingleUse

PRINCIPAL DISPLAY PANEL

201.08