71927-012 American Safety & First Aid Burn Spray

Manufacturer
Orazen Inc
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:18

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Lidocaine HCL 2%

Purpose

External analgesic

Uses

Uses

for the temporary relief of pain associated with minor burns

Warnings

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens symptoms persist more than 7 days condition clears up and occurs again within a few days

Directions And Dosage

Directions

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 Label Information

Inactive ingredients

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

Questions?

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

Package Label - Principal Display Panel

Label Images#

2
2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN2
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD2
1010769lidocaine hydrochloride 2 % Topical SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-012-01American Safety First Aid59.1 mL in 1 BOTTLE, SPRAYSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-012AMERICAN SAFETY FIRST AID (LIDOCAINE HCL) SPRAY [ORAZEN INC]2Current NDC, Legacy NDC, 1 package rows20240116_ea2f776b-dfd0-6ce4-e053-2995a90af009.zip

Products#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

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

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

Questions?

OTC - QUESTIONS SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML