Drug Facts - For use by licensed professionals only

Vasocaine by

Drug Labeling and Warnings

Vasocaine by is a Otc medication manufactured, distributed, or labeled by Dermal Source, Inc., HTO Nevada, Inc. (dba Kirkman). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VASOCAINE- lidocaine hcl, epinephrine hcl spray 
Dermal Source, Inc.

----------

Drug Facts - For use by licensed professionals only


Active Ingredients Purpose
Lidocaine HCl   5% Topical Anesthetic
Epinephrine HCl.01% Vasoconstrictor

Uses: External Use Only.  
Temporarily relieves pain, itching or swelling associated
with anorectal disorders or pain sensitive procedures.

WARNINGS: Keep out of reach of children

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 this product you may notice temporary blanching
or redness of the skin where liquid is applied.

Directions:  Sensitivity test advised prior to use.

Apply sparingly to affected area. Wait until anesthetic
effect occurs (90 seconds). Discontinue use if sensitivity 
occurs. Wash Vasocaine off completely before tattooing.

Inactive Ingredients: Purified Water, Propylene Glycol,
Sodium Metabisulfite, Citric Acid Diazolidinyl Urea,
Methyl Paraben, Propyl Paraben, and Disodium EDTA.

Other information: Store in cool dark place or refrigerate
and out of reach of children. Discard after expiration date.

Questions? Contact distributor on product label.

PRINCIPAL DISPLAY PANEL

FIVE-STAR

Vasocaine

Fast acting
anesthetic to
reduce pain
and swelling

4 oz.

NDC: 80069-007-01

Distributed by:
DERMAL SOURCE
Portland, OR 97232

www.dermalsource.com
1-866-568-3223

label
VASOCAINE 
lidocaine hcl, epinephrine hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80069-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous50 mg  in 1 mL
Epinephrine Hydrochloride (UNII: WBB047OO38) (Epinephrine - UNII:YKH834O4BH) Epinephrine Hydrochloride.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80069-007-01118.294 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/200503/27/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01506/01/200503/27/2024
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-007)

Revised: 5/2024
 

Trademark Results [Vasocaine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VASOCAINE
VASOCAINE
78411780 3101758 Live/Registered
DERMAL SOURCE
2004-05-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.