Dynarex Burn Cream

Manufacturer: Dynarex Corporation | Galentic Pharma (India) Pvt. Ltd.
Effective date: 2016-04-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:45:41

Label at a glance#

ProductDynarex Burn Cream

Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE

Label structure11 sections

Indications and uses

For temporary relief of pain and itching associated with: Sunburn Minor burns, Insect bites, Minor skin irritation, Cuts and Scrapes

Dosage and administration

Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 or 4 times daily. may be covered with a sterile bandage Children under 2 years consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

OTC - PURPOSE SECTION

Temporary relief of pain and itching.

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with:

Sunburn
Minor burns,
Insect bites,
Minor skin irritation,
Cuts and
Scrapes

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

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

Stop Use

OTC - STOP USE SECTION

Stop Use and ask a doctor:

If condition worsens or,
if symptoms persist for more than 7 days or clear up and occur again in a few days.
If pregnant or breast feeding, ask a health professional before use.

Do Not Use

OTC - DO NOT USE SECTION

Do Not Use:

In the eyes
Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
In large quantities, particularly over raw surfaces or blistered areas.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over:

clean the affected area
apply a small amount of this product on the area 3 or 4 times daily.
may be covered with a sterile bandage

Children under 2 years

consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben

Other Information

SPL UNCLASSIFIED SECTION

Other Information

store in a cool, dry area
59o to 79o F (15o to 25o C)
Tamper evident sealed packets do not use any open or torn packets

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dynarex Burn Cream

DFAC.jpg

Burn Cream

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1012100	Benzalkonium/Lidocaine (Topical)	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	4
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	4
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0616784116525	GTIN-13: 0616784116525 EAN-13: 0616784116525 GTIN-12: 616784116525 UPC-A: 616784116525 GTIN storage (14 digits): 00616784116525	DFAC.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67777-412-01	2020-01-31	C162847	48780-1	9d75b9d0-1f03-f424-e053-dadaa90a57ce	Dynarex Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67777-412-01	Dynarex Burn Cream	0.9 g in 1 PACKET	CREAM	0.9		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-412	DYNAREX BURN CREAM (LIDOCAINE) CREAM [DYNAREX CORPORATION]	4	Legacy NDC, 1 package rows	20160411_b3fe8c85-03cd-44d9-8c28-edb9c05a8115.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	3
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	3
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	3
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	3
METHYLCELLULOSE (25 MPA.S)	INACTIVE INGREDIENT	BI55GG2WLI	3
METHYLPARABEN SODIUM	INACTIVE INGREDIENT	CR6K9C2NHK	3
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Dynarex Burn Cream
Lidocaine
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS
BENZALKONIUM CHLORIDE
BENZALKONIUM
ISOPROPYL MYRISTATE
METHYLCELLULOSE (25 MPA.S)
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
DIMETHICONE
CETETH-20
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
GLYCERIN
EDETATE SODIUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67777-412	67777-412-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYLCELLULOSE (25 MPA.S)	BI55GG2WLI	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
DIMETHICONE	92RU3N3Y1O	IACT
CETETH-20	I835H2IHHX	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT
GLYCERIN	PDC6A3C0OX	IACT
EDETATE SODIUM	MP1J8420LU	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 183 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	LOTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN SODIUM	METHYLPARABEN SODIUM	CR6K9C2NHK	TABLET / ORAL	0.19 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN SODIUM	METHYLPARABEN SODIUM	CR6K9C2NHK	TABLET, ORALLY DISINTEGRATING / ORAL	0.3 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	CREAM / TOPICAL		429 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN SODIUM	PROPYLPARABEN SODIUM	625NNB0G9N	TABLET / ORAL	0.06 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / OPHTHALMIC	0.1 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates

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
f24d37cd-5b6d-4b78-8821-92d3ea4afd35			b3fe8c85-03cd-44d9-8c28-edb9c05a8115	2016-04-11	Warnings	Exact identifier spl id: f24d37cd-5b6d-4b78-8821-92d3ea4afd35 spl set id: b3fe8c85-03cd-44d9-8c28-edb9c05a8115

Reported adverse events (FAERS/openFDA)#

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

Dynarex Burn Cream

Label at a glance#

Indications and uses

Dosage and administration

Label contents#

Full prescribing information#

Active Ingredients

Purpose

Uses

Warnings

KEEP OUT OF REACH OF CHILDREN

Stop Use

Do Not Use

Directions

Inactive ingredients

Other Information

Principal Display Panel

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#