Label: BLUE GEL ANESTHETIC- lidocaine hcl, tetracaine hcl, racepinephrine hcl gel
- NDC Code(s): 80069-013-01
- Packager: Dermal Source, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 13, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
-
WARNINGS
Warnings: Avoid contact with eyes.
Do not swallow. Keep out of children's reach.
Do not use if you have- A history of severe 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
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BLUE GEL ANESTHETIC
lidocaine hcl, tetracaine hcl, racepinephrine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80069-013 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 g Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV) Tetracaine Hydrochloride 10 mg in 1 g Racepinephrine Hydrochloride (UNII: 336096P2WE) (Racepinephrine - UNII:GR0L9S3J0F) Racepinephrine 0.1 mg in 1 g 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) Epinephrine Hydrochloride (UNII: WBB047OO38) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Citric Acid Monohydrate (UNII: 2968PHW8QP) Fd&C Yellow No. 5 (UNII: I753WB2F1M) Fd&C Blue No. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80069-013-01 28.3495 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/07/2022 Labeler - Dermal Source, Inc. (183535629) Establishment Name Address ID/FEI Business Operations HTO Nevada, Inc. (dba Kirkman) 117115846 manufacture(80069-013)