Fire Out

Manufacturer
Randob Ltd. | Multi-Pack Solutions
Effective date
2019-04-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:12

Label at a glance#

ProductFire Out
Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

▪ Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.

Dosage and administration

Children under 2 yrs. ▪ Do not use ▪ Consult doctor Adults and children 2 yrs. and older ▪ Clean area ▪ Apply to affected area as needed not more than 3 to 4 times a day.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine USP 20%

Menthol USP 1%

Purpose

OTC - PURPOSE SECTION

(for pain) Topical Anesthetic

(anti-itch) Antipruritic

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.

Warnings

WARNINGS SECTION

  • For external use only
  • Do not apply over large areas of the body
  • Avoid contact with eyes, mouth, and mucous membranes

Directions

DOSAGE & ADMINISTRATION SECTION

Children under 2 yrs.

  • Do not use
  • Consult doctor

Adults and children 2 yrs. and older

  • Clean area
  • Apply to affected area as needed not more than 3 to 4 times a day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, Isopropyl Alcohol 15%, PEG-8 Laurate, Water.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

KILLS THE PAIN

STOPS THE ITCH

FIRE OUT™

INSTANT PAIN RELIEF

from:

Fire Ant Stings

also from:

  • Mosquito Bites Insect Bites
  • Jellyfish Stings Bee Stings

MAXIMUM STRENGTH

PAIN RELIEVING LIQUID

NO-MESS ROLL-ON

1.7 fl oz (50 ml)

MADE IN THE USA

DUAL ACTION

carton-label-bottle
carton-label-bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1552282benzocaine 20 % / menthol 1 % Topical SolutionPSN3
1866401Fire Out 20 % / 1 % Topical SolutionPSN3
1866401benzocaine 200 MG/ML / menthol 10 MG/ML Topical Solution [Fire Out]SBD3
1552282benzocaine 200 MG/ML / menthol 10 MG/ML Topical SolutionSCD3
1552282benzocaine 20 % / menthol 1 % Topical SolutionSY3
1866401Fire Out (benzocaine 20 % / menthol 1 % ) Topical SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-300-10Fire Out1 in 1 CARTONSOLUTION13
52412-300-10Fire Out50 mL in 1 BOTTLE, WITH APPLICATORSOLUTION503
52412-300-20Fire Out5 in 1 BLISTER PACKSOLUTION53
52412-300-20Fire Out0.5 mL in 1 VIAL, SINGLE-USESOLUTION0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-300FIRE OUT (BENZOCAINE AND MENTHOL) SOLUTION [RANDOB LTD.]3Current NDC, Legacy NDC, 4 package rows20190416_77ab634e-13d4-4f5f-87c8-73976e65a842.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-30052412-300-10, 52412-300-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
Fire OutBENZOCAINE AND MENTHOLRandob Ltd.77ab634e-13d4-4f5f-87c8-73976e65a8422019-04-12WarningsExact identifier
ndc (package): 52412-300-10
ndc (package): 52412-300-20
ndc (product): 52412-300
ndc11 (package): 52412030020
ndc11 (package): 52412030010
spl id: a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a
spl set id: 77ab634e-13d4-4f5f-87c8-73976e65a842

Reported adverse events (FAERS/openFDA)#

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