ZONE 1- lidocaine hcl cream

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]

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

Indications: Temporarily relieves pain associated with anorectal disorders.

WARNINGS

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

DO NOT USE

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.

WHEN USING

STOP USE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

STORAGE AND HANDLING

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

QUESTIONS

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

INGREDIENTS AND APPEARANCE

ZONE 1 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-003
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80069-003-01	14.1748 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	11/01/2004

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
HTO Nevada, Inc. (dba Kirkman)		117115846	manufacture(80069-003)