BurnZone

Manufacturer: MedZone Products LLC | Richard Hamer Associates LLC | Biomed Laboratories LLC | Microconsult Inc. | Ceutical Laboratories Inc.
Effective date: 2018-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:54:28

Label at a glance#

ProductBurnZone

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

Temporarily relieves pain and itching due to minor burns, minor cuts, minor scrapes, sunburn, insect bites, rashes, minor skin irritations.

Dosage and administration

dults and children 2 years of age and over: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Contacts and useful links#

PhoneLabel contact(866-633-9663

Websitewww.medzonecorp.com

www.medzonecorp.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to minor burns, minor cuts, minor scrapes, sunburn, insect bites, rashes, minor skin irritations.

Warnings

WARNINGS SECTION

For external use onlyDrug Facts Label

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a physician if

OTC - STOP USE SECTION

Allergic reaction occirs
condition worsens or does not improve within 7 days
symptoms clear up and return withina few days
redness, irritation, swelling, pain or other symptoms begin or increase

Do not use

OTC - DO NOT USE SECTION

in or near the eyes
in large quantities, particularly over raw surfaces or blistered areas

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

dults and children 2 years of age and over: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature. Avoid execssive heat or cold.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Vera Leaf, Alpha-Tocopheryl Acetate, Carboxypolymethylene, Chamaemelum Nobile Flower, Cetostearyl Alchol, Cetyl Alcohol, Clove Oil, Duazolidinyl Urea, Glycerin, Green Tea Leaf, Hyaluronate Sodium, Hydrogenated Soybean Lecithin, Iodopropynyl Butylcarbamate, Medium-Chain Triglycerides, Oleic Acid, Panthenol, Peppermint Oil, Polyoxyl 20 Cetostearyl Ether, Tea Tree Oil, Trolamine, Water

Questions?

OTC - QUESTIONS SECTION

Toll-free 866-MEDZONE (866-633-9663)

www.medzonecorp.com info@medzonecorp.com

HOW SUPPLIED SECTION

Distributed by MedZone Products LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1011326	lidocaine HCl 1 % Topical Cream	PSN	2
1011326	lidocaine hydrochloride 10 MG/ML Topical Cream	SCD	2
1011326	lidocaine hydrochloride 1 % Topical Cream	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70338-621-12	2023-07-28	C162847	48780-1	0191ceaa-6c10-198a-e063-dbdaa90aec3e	37898703-be54-2853-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70338-621-12	BurnZone	3.6 g in 1 POUCH	CREAM	3.6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70338-621	BURNZONE (PAIN RELIEVING CREAM) CREAM [MEDZONE PRODUCTS LLC]	2	Legacy NDC, 1 package rows	20180212_37898703-be54-2853-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

BurnZone
Pain Relieving Cream
CARBOMER 934
CHAMAEMELUM NOBILE FLOWER
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
IODOPROPYNYL BUTYLCARBAMATE
OLEIC ACID
PANTHENOL
TEA TREE OIL
CLOVE OIL
GLYCERIN
GREEN TEA LEAF
HYALURONATE SODIUM
HYDROGENATED SOYBEAN LECITHIN
MEDIUM-CHAIN TRIGLYCERIDES
PEPPERMINT OIL
POLYOXYL 20 CETOSTEARYL ETHER
ALOE VERA LEAF
LIDOCAINE HYDROCHLORIDE
LIDOCAINE
ALPHA-TOCOPHEROL ACETATE
ALLANTOIN
DIAZOLIDINYL UREA
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70338-621	70338-621-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOMER 934	Z135WT9208	IACT
CHAMAEMELUM NOBILE FLOWER	O2T154T6OG	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETYL ALCOHOL	936JST6JCN	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
OLEIC ACID	2UMI9U37CP	IACT
PANTHENOL	WV9CM0O67Z	IACT
TEA TREE OIL	VIF565UC2G	IACT
CLOVE OIL	578389D6D0	IACT
GLYCERIN	PDC6A3C0OX	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
HYDROGENATED SOYBEAN LECITHIN	H1109Z9J4N	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ALLANTOIN	344S277G0Z	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
65085ba2-e779-8823-e053-2991aa0a90d0			37898703-be54-2853-e054-00144ff88e88	2018-02-12	Warnings	Exact identifier spl id: 65085ba2-e779-8823-e053-2991aa0a90d0 spl set id: 37898703-be54-2853-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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