ZONE 2- lidocaine hcl, epinephrine gel 
Dermal Source, Inc.

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Drug Facts - For use by licensed professionals only.


Active Ingredients (in each cc)Purpose
Lidocaine HCL4%Topical Anesthetic
Epinephrine0.01%Vasoconstrictor

Uses: Temporarily relieves local pain and swelling on irritated hemorrhoidal tissue or other anorectal disorders.

WARNINGS: External use only.
Do not swallow. Keep out of children's reach.

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

  • You may notice temporary blanching, skin irritation or sensitivity of the skin where gel is applied
  • You may not have pain - avoid sources of heat or injury
  • You may have delayed swelling after drug is dissipated

Directions:  Sensitivity test advised prior to use.

Apply sparingly to affected area up to four times daily and cover with occlusive dressing. Product is ineffective when applied to intact skin. Wait until anesthetic effect occurs (2-5 minutes). Remove product.

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

Other information: Store in a cool dark place or refrigerate. Discard after expiration date.

Questions? Contact distributor on product label for further questions.

PRINCIPAL DISPLAY PANEL

NDC Code: 80069-015-01

MAXIMUM
Zone 2

TOPICAL ANALGESIC


1 oz.

for use during a pain sensitive procedure

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

label
ZONE 2 
lidocaine hcl, epinephrine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80069-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous40 mg  in 1 mL
Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80069-015-0129.5735 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01504/01/2022
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-015)

Revised: 5/2024
 
Dermal Source, Inc.