Drug Facts - For use by licensed professionals only

Zone 2 by

Drug Labeling and Warnings

Zone 2 by is a Otc medication manufactured, distributed, or labeled by Dermal Source, Inc., KIRKMAN LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZONE 2- lidocaine hcl gel 
Dermal Source, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts - For use by licensed professionals only.

• Active Ingredients (in each cc): Purpose
• Lidocaine HCl 5%: Topical Anesthetic

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
over 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, L-Epinephrine, 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

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

NDC Code 80069-004-01

ZONE 2 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Propylene Glycol (UNII: 6DC9Q167V3)
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Epinephrine Hydrochloride (UNII: WBB047OO38)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80069-004-01	28.3495 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2004	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2004	04/01/2022

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN GROUP, INC.		095275447	manufacture(80069-004)

Revised: 4/2022

Document Id: 341420c3-5f1f-4d36-a399-13b3b5c0d847

34390-5

Set id: d67bb013-42f6-4c49-8f1e-c659ec8013e2

Version: 6

Effective Time: 20220401