Drug Facts - For use by licensed professionals only

Zone 1 by

Drug Labeling and Warnings

Zone 1 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 1- lidocaine hcl cream 
Dermal Source, Inc.

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Drug Facts - For use by licensed professionals only.


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

Indications: Temporarily relieves pain associated with anorectal disorders.

Warnings: Do not swallow. Keep out of children's reach.
External use only on intact skin.

Do not use if pregnant or breast-feeding.
Do not use if you have seizures or liver disease.
Do not use if you have a known allergy or sensitivity to any
component of this product. If sensitivity occurs, discontinue
use, immediately cleanse skin and seek medical attention. If
condition worsens or if symptoms persist for more than seven
days or clear up and occur again, discontinue use and consult
a doctor. Do not use in large quantities, particularly over raw
surfaces or blistered areas. Avoid contact with eyes. In case of
contact with eyes, rinse immediately with copious amounts of
eyewash and seek treatment by a medical professional. If
accidentally swallowed, get medical attention immediately.

Directions:  Sensitivity test advised prior to use.

Apply a moderately thick layer of cream to intact skin. Discontinue use if
sensitivity occurs. Wait for numbness to develop. For thinner skin (eye
area) wait 10-15 minutes. For thicker skin, best results are obtained
after 1 hour of application. Cleanse area thoroughly before procedure.

Inactive Ingredients: Purified Water, Glyceryl Stearate
(and) PEG 100-Stearate, Petrolatum, Stearic Acid, Cetyl
Alcohol, Xanthan Gum, Glycerol Monostearate, Sodium
Hydroxymethlyglycinate, Triethanolamine, Propyl
Paraben, Methyl Paraben, and BHT.

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

Questions? Contact distributor on product label for further questions.

PRINCIPAL DISPLAY PANEL

MAXIMUM

Zone 1

TOPICAL ANALGESIC

7 pH

1/2 oz.

5% Lidocaine Cream

for use before a
pain sensitive procedure


Distributed by: DERMAL SOURCE
Portland, OR 97232

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

NDC: 80069-003-01

label
ZONE 1 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80069-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Peg-100 Stearate (UNII: YD01N1999R)  
Petrolatum (UNII: 4T6H12BN9U)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Hydroxymethylglycinate (UNII: DIG6BWZ9XT)  
Trolamine (UNII: 9O3K93S3TK)  
Propylparaben (UNII: Z8IX2SC1OH)  
Methylparaben (UNII: A2I8C7HI9T)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80069-003-0114.1748 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/200401/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01511/01/200401/25/2024
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-003)

Revised: 5/2024
 

Trademark Results [Zone 1]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZONE 1
ZONE 1
78411782 3005130 Live/Registered
DERMAL SOURCE
2004-05-01

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