Zone 2

Manufacturer
Dermal Source, Inc. | HTO Nevada, Inc. (dba Kirkman)
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:02:54

Label at a glance#

ProductZone 2
Active ingredientLidocaine Hydrochloride, Epinephrine
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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 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

OTC - WHEN USING SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

Directions:  Sensitivity test advised prior to use.

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

Questions? Contact distributor on product label for further questions.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80069-015ZONE 2 (LIDOCAINE HCL, EPINEPHRINE) GEL [DERMAL SOURCE, INC.]2Unmatched20240511_46d0964d-159f-4ddb-8d48-fb2fb0df1c60.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80069-01580069-015-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
440d9b25-a423-9983-e063-6294a90ad06746d0964d-159f-4ddb-8d48-fb2fb0df1c602025-11-20WarningsExact identifier
spl set id: 46d0964d-159f-4ddb-8d48-fb2fb0df1c60

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.