Top Safety First Aid Burn Cream

Manufacturer
Top Safety Products Company Inc
Effective date
2019-03-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:58:46

Label at a glance#

ProductTop Safety First Aid 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

Top Safety First Aid Burn Cream

Top Safety.jpg

TS First Aid BurnTS First Aid Burn

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN6
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD6
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51395-412-012021-01-29C16284748780-1ba0f9c33-3a3b-a910-e053-dadaa90a0b85TS-605-365T Top Safety First Aid Burn Cream NDC 51395-412-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51395-412-01Top Safety First Aid Burn Cream2000 in 1 BOXCREAM20006
51395-412-01Top Safety First Aid Burn Cream0.9 g in 1 PACKETCREAM0.96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51395-412TOP SAFETY FIRST AID BURN CREAM (LIDOCAINE) CREAM [TOP SAFETY PRODUCTS COMPANY INC]6Legacy NDC, 2 package rows20190313_2f9f0d6d-2039-4c21-9d04-02757438be0a.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51395-41251395-412-01

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
83ea3e25-1a91-0e37-e053-2991aa0a35e12f9f0d6d-2039-4c21-9d04-02757438be0a2019-03-12WarningsExact identifier
spl id: 83ea3e25-1a91-0e37-e053-2991aa0a35e1
spl set id: 2f9f0d6d-2039-4c21-9d04-02757438be0a

Reported adverse events (FAERS/openFDA)#

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