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NDC 70338-0621-12 BurnZone 10 mg/g Details

BurnZone 10 mg/g

BurnZone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by MedZone Products LLC. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	70338-0621
Product ID	70338-621_65085ba2-e779-8823-e053-2991aa0a90d0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BurnZone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pain Relieving Cream
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	MedZone Products LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70338-0621-12 (70338062112)

Pricing Information	N/A
NDC Package Code	70338-621-12
Billing NDC	70338062112
Package	3.6 g in 1 POUCH (70338-621-12)
Marketing Start Date	2016-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 37898703-be54-2853-e054-00144ff88e88 Details

Active Ingredient

Lidocaine HCl 1%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a physician if

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

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

Keep out of reach of children

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

Directions

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

Store at room temperature. Avoid execssive heat or cold.

Inactive Ingredients

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?

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

www.medzonecorp.com [email protected]

SPL UNCLASSIFIED SECTION

Distributed by MedZone Products LLC

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURNZONE

pain relieving cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70338-621
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70338-621-12	3.6 g in 1 POUCH; Type 0: Not a Combination Product	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2016

Labeler - MedZone Products LLC (080083739)

Registrant - Richard Hamer Associates LLC (067731889)

Name	Address	ID/FEI	Business Operations
Establishment
Biomed Laboratories LLC		055329696	manufacture(70338-621) , pack(70338-621)

Name	Address	ID/FEI	Business Operations
Establishment
Microconsult Inc.		062183608	analysis(70338-621)

Name	Address	ID/FEI	Business Operations
Establishment
Ceutical Laboratories Inc.		789485153	analysis(70338-621)

Revised: 2/2018

Document Id: 65085ba2-e779-8823-e053-2991aa0a90d0

Set id: 37898703-be54-2853-e054-00144ff88e88

Version: 2

Effective Time: 20180212