RxNorm Names

Not yet provided

KDS LAB LIQUID STYPTIC (lidocaine hydrochloride, zinc chloride, alcohol) liquid
[KDS Lab]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=59c2b84b-9c7c-4d4e-a673-f154ccd92af4

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active Ingredient:

Lidocaine HCl 4% ………………………………………………
Zinc Chloride 40% ………………………………………………
Alcohol Denat. 20%……..….……………………………………

Purpose:

Antiseptic
Antiseptic
Antiseptic

Use:

First aid to help prevent bacterial contamination in minor cuts and scrapes.

Warnings

For External Use Only. Flammable.
Keep away from fire or flame.

Do not use

• in the eyes • excessive amounts over large areas of
the body • longer than one week unless directed by a doctor • on
infected areas or wounds that are draining • with other first-aid products
such as lotions and creams • over sutures • lon mucous membranes

In case of deep or punctured wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if

• condition persists or gets
worse • infection occurs

When using this product

• do not pucture or incinerate, do not
store at temperatures above 120°F • intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.

Keep out of reach of children.

f swallowed, get medical help or call a
Poison Control Center right away.

Directions

Clean affected area • Apply a small amount on the area 1-3 times
a day • Let dry • A second coating may be applied for extra protection • To
remove, apply more Liquid Styptic and quickly wipe off.

Other Information

• Store at room temperature away from heat • may
temporarily sting upon application • do not allow to come into contact with floors,
countertops or other finished surfaces – will stain.

Inactive Ingredients

• Water/Aqua/Eau, Blue 1, Yellow 5

Place Holder Text

KDS LAB LIQUID STYPTIC
lidocaine hydrochloride, zinc chloride, alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24488-040
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE)	LIDOCAINE HYDROCHLORIDE	39.9680796 mg in 1 mL
ZINC CHLORIDE (ZINC CATION)	ZINC CHLORIDE	400.018936 mg in 1 mL
ALCOHOL (ALCOHOL)	ALCOHOL	199.975654 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
FD&C BLUE NO. 1
FD&C YELLOW NO. 5

Packaging
#	Item Code	Package Description
1	NDC:24488-040-80	14.786 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/03/2012

Labeler - KDS Lab (961956229)

Registrant - Creation's Garden Natural Products (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creation's Garden Natural Products		961956229	manufacture(24488-040)

Revised: 10/2012

Document Id: ae3fcc4e-4c22-4411-aa31-b6654141cb96

Set id: 59c2b84b-9c7c-4d4e-a673-f154ccd92af4

Version: 1

Effective Time: 20121003

KDS Lab

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