FDA.reportPublic FDA data

71927-012 American Safety & First Aid Burn Spray

Manufacturer
Orazen Inc | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2026-09-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-10 00:01:00

Label at a glance#

ProductAmerican Safety First Aid
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

for the temporary relief of pain associated with minor burns

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 2%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

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

in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist more than 7 days
  • condition clears up and occurs 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • you may report a serious adverse reaction to this product to 1-866-651-3660

Inactive ingredients

INACTIVE INGREDIENT SECTION

aminomethyl propanol, glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, water

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660
Mon-Fri 8:00am-5:00pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71927-01271927-012-01

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
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
HYPROMELLOSES3NXW29V3WOIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OCTOXYNOL 97JPC6Y25QSIACT
TEA TREE OILVIF565UC2GIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYL PROPANOLLU49E6626QIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-01-15full-release2026-06-01 00:07:18

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
ndc (package): 71927-012-01
ndc (product): 71927-012
ndc11 (package): 71927001201
spl id: 5aebc911-05c4-d91c-e063-6294a90a8924
spl set id: ea2f776b-dfd0-6ce4-e053-2995a90af009

Reported adverse events (FAERS/openFDA)#

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