Label: VASOCAINE- lidocaine hcl, epinephrine hcl spray
- NDC Code(s): 80069-016-01
- Packager: Dermal Source, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
-
DO NOT USE
Do not use if you have
- seizures or liver disease
- if pregnant or breast feeding
- a known allergy or sensitivity to any of the components of this
product. If sensitivity occurs, discontinue use, and seek medical
attention. If condition worsens or symptoms persist for more than
seven days or clear up and occur again within a few days,
discontinue use of this product and consult a doctor. Do not use in
large quantities, particularly over raw surfaces or blistered areas.
Avoid direct contact with eyes. If contact should occur,
irrigate with copious amounts of sterile saline and seek
medical attention. DO NOT SWALLOW. If you have swallowed
this product seek medical attention immediately. - WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VASOCAINE
lidocaine hcl, epinephrine hcl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80069-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous 40 mg in 1 mL Racepinephrine Hydrochloride (UNII: 336096P2WE) (Racepinephrine - UNII:GR0L9S3J0F) Racepinephrine .1 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Metabisulfite (UNII: 4VON5FNS3C) Citric Acid Monohydrate (UNII: 2968PHW8QP) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80069-016-01 118.294 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 06/01/2005 Labeler - Dermal Source, Inc. (183535629) Establishment Name Address ID/FEI Business Operations HTO Nevada, Inc. (dba Kirkman) 117115846 manufacture(80069-016)
