Label: ALOCANE EMERGENCY BURN- lidocaine hydrochloride gel
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NDC Code(s):
68229-201-01,
68229-201-02,
68229-201-03,
68229-201-04, view more68229-201-05, 68229-201-06, 68229-201-07, 68229-201-08, 68229-201-09, 68229-201-10, 68229-201-11, 68229-201-12, 68229-201-13, 68229-201-14, 68229-201-15, 68229-201-16, 68229-201-17, 68229-201-18
- Packager: Quest Products, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only. Avoid contact with eyes.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel 2.5 fl oz tube
- PRINCIPAL DISPLAY PANEL -- ALOCANE Burn Gel Pump
- PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel Single Use 45 Count
- PRINCIPAL DISPLAY PANEL - ALOCANE Burn Spray 3.5 fl oz
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INGREDIENTS AND APPEARANCE
ALOCANE EMERGENCY BURN
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68229-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 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 1 NDC:68229-201-02 1 in 1 CARTON 03/01/2019 1 NDC:68229-201-01 110 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68229-201-03 110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/01/2020 3 NDC:68229-201-05 24 in 1 CARTON 03/01/2020 3 NDC:68229-201-04 3.4 mL in 1 PACKET; Type 0: Not a Combination Product 4 NDC:68229-201-07 45 in 1 CARTON 03/01/2020 4 NDC:68229-201-06 3.4 mL in 1 PACKET; Type 0: Not a Combination Product 5 NDC:68229-201-08 103.507 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/01/2020 6 NDC:68229-201-11 133.081 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/01/2020 7 NDC:68229-201-10 1 in 1 CARTON 03/01/2019 7 NDC:68229-201-09 118.294 mL in 1 TUBE; Type 0: Not a Combination Product 8 NDC:68229-201-14 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2019 12/31/2024 9 NDC:68229-201-12 1 in 1 KIT 03/01/2019 09/30/2022 9 NDC:68229-201-15 800 mL in 1 BAG; Type 0: Not a Combination Product 10 NDC:68229-201-13 1 in 1 CARTON 03/01/2019 10 NDC:68229-201-15 800 mL in 1 BAG; Type 0: Not a Combination Product 11 NDC:68229-201-18 1 in 1 CARTON 12/09/2021 11 NDC:68229-201-17 22 mL in 1 TUBE; Type 0: Not a Combination Product 12 NDC:68229-201-16 124 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/11/2022 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)