1168

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: 1168
Generic name: 1168 BURN SPRAY
Manufacturer: Dynarex Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 1183a4f5-f875-dfb0-e063-6394a90af35f
SPL ID: 1183a4f5-f876-dfb0-e063-6394a90af35f
Version: 1
Effective date: 2024-02-16
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:51:41

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		1168	openfda.brand_name
generic name		1168 BURN SPRAY	openfda.generic_name
manufacturer name		Dynarex Corporation	openfda.manufacturer_name
ndc	package	67777-013-05	openfda.package_ndc
ndc	package	67777-013-06	openfda.package_ndc
ndc	product	67777-013	openfda.product_ndc
ndc11	package	67777001305	derived:openfda.package_ndc
ndc11	package	67777001306	derived:openfda.package_ndc
spl id		1183a4f5-f876-dfb0-e063-6394a90af35f	id
spl set id		1183a4f5-f875-dfb0-e063-6394a90af35f	set_id
unii		V13007Z41A	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For External Use Only Do not use • 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 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 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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