Label: ZONE 2- lidocaine hcl, epinephrine gel
- NDC Code(s): 80069-012-01
- Packager: Dermal Source, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 3, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
-
DO NOT USE
Do not use if you have
- A history of sever liver disease or impairment.
- A known allergy or sensitivity to any of the components of this product. If sensitivity occurs, consult a doctor if condition worsens or does not improve in seven days, or clears up and occurs again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Do not use if pregnant or nursing. In case of accidental contact with eyes, rinse immediately with copious amounts of eyewash. Seek care by an eye care physician. If accidentally swallowed, get medical help immediately.
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZONE 2
lidocaine hcl, epinephrine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80069-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous 50 mg in 1 mL Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B) Propylene Glycol (UNII: 6DC9Q167V3) Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D) Sodium Metabisulfite (UNII: 4VON5FNS3C) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Citric Acid Monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80069-012-01 29.5735 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2022 06/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 04/01/2022 06/24/2024 Labeler - Dermal Source, Inc. (183535629) Establishment Name Address ID/FEI Business Operations HTO Nevada, Inc. (dba Kirkman) 117115846 manufacture(80069-012)