Label: SUNBURNT PLUS- lidocaine hydrochloride gel
- NDC Code(s): 68229-600-01, 68229-600-02
- Packager: Quest Products, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
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- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL - 118mL Tube Carton
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INGREDIENTS AND APPEARANCE
SUNBURNT PLUS
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68229-600 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) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) PANTHENOL (UNII: WV9CM0O67Z) CUCUMBER SEED (UNII: BT3S9L53JK) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68229-600-01 1 in 1 CARTON 07/01/2020 1 NDC:68229-600-02 118.294 mL 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 Drug M017 07/01/2020 Labeler - Quest Products, LLC. (075402441) Establishment Name Address ID/FEI Business Operations Fill Tech USA 926433855 manufacture(68229-600)