VASOCAINE- lidocaine hcl, epinephrine hcl spray

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]

ACTIVE INGREDIENT

Active Ingredients		Purpose
Lidocaine HCl	4%	Topical Anesthetic
Racepinephrine HCl	.01%	Vasoconstrictor

INDICATIONS & USAGE

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

WARNINGS

WARNINGS: Keep out of reach of children

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

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

STOP USE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

STORAGE AND HANDLING

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

QUESTIONS

Questions? Contact distributor on product label.

PRINCIPAL DISPLAY PANEL

FIVE-STAR

Vasocaine

Fast acting
anesthetic to
reduce pain
and swelling

4 oz.

NDC: 80069-016-01

Distributed by:
DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223

INGREDIENTS AND APPEARANCE

VASOCAINE 
lidocaine hcl, epinephrine hcl spray

Product 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)