1168 Burn Spray

Manufacturer: Dynarex Corporation
Effective date: 2024-02-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:09:02

Label at a glance#

Product1168

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure9 sections

Dosage and administration

• Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily. • Children under 12 years of age: Consult a doctor before use

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use(s)

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with minor burns

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

• Over large areas of the body, particularly over raw surfaces, or blistered areas

• Near eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily.

• Children under 12 years of age: Consult a doctor before use

Other Information

OTHER SAFETY INFORMATION

• Store at 20º-25ºC (68º-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine

Questions?

OTC - QUESTIONS SECTION

1-888-Dynarex Monday - Friday, 9AM - 5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1168_IN_MASTER1168 Label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67777-013-05	1168	24 in 1 CASE	SPRAY	24		1
67777-013-06	1168	59.1 mL in 1 BOTTLE, SPRAY	SPRAY	59.1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-013	1168 (1168 BURN SPRAY) SPRAY [DYNAREX CORPORATION]	1	Current NDC, 2 package rows	20240229_1183a4f5-f875-dfb0-e063-6394a90af35f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

1168
1168 Burn Spray
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
WATER
OCTOXYNOL 9
LIDOCAINE HYDROCHLORIDE
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS
POLYOXYL 40 HYDROGENATED CASTOR OIL
GLYCERIN
PHENOXYETHANOL
TROLAMINE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67777-013	67777-013-06, 67777-013-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL	VIF565UC2G	IACT
WATER	059QF0KO0R	IACT
OCTOXYNOL 9	7JPC6Y25QS	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
TROLAMINE	9O3K93S3TK	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
PROPYLENE GLYCOL	6DC9Q167V3	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
1168	1168 BURN SPRAY	Dynarex Corporation	1183a4f5-f875-dfb0-e063-6394a90af35f	2024-02-16	Warnings	Exact identifier ndc (package): 67777-013-05 ndc (package): 67777-013-06 ndc (product): 67777-013 ndc11 (package): 67777001305 ndc11 (package): 67777001306 spl id: 1183a4f5-f876-dfb0-e063-6394a90af35f spl set id: 1183a4f5-f875-dfb0-e063-6394a90af35f

Reported adverse events (FAERS/openFDA)#

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