Search by Drug Name or NDC

NDC 52412-0300-10 Fire Out 200; 10 mg/mL; mg/mL Details

Fire Out 200; 10 mg/mL; mg/mL

Fire Out is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Randob Ltd.. The primary component is BENZOCAINE; MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	52412-0300
Product ID	52412-300_a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fire Out
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine and Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	200; 10
Active Ingredient Units	mg/mL; mg/mL
Substance Name	BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Labeler Name	Randob Ltd.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52412-0300-10 (52412030010)

Pricing Information	N/A
NDC Package Code	52412-300-10
Billing NDC	52412030010
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (52412-300-10) / 50 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2016-02-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 77ab634e-13d4-4f5f-87c8-73976e65a842 Details

Active ingredient

Benzocaine USP 20%

Menthol USP 1%

Purpose

(for pain) Topical Anesthetic

(anti-itch) Antipruritic

Keep Out of Reach of Children

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

Uses

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

Warnings

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

Directions

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

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

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

INGREDIENTS AND APPEARANCE

FIRE OUT

benzocaine and menthol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52412-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-8 LAURATE (UNII: 762O8IWA10)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE (Blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52412-300-10	1 in 1 CARTON	02/15/2016
1		50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC:52412-300-20	5 in 1 BLISTER PACK	03/15/2017	03/15/2017
2		0.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/15/2016

Labeler - Randob Ltd. (061995007)

Registrant - Randob Ltd. (061995007)

Name	Address	ID/FEI	Business Operations
Establishment
Multi-Pack Solutions		557434805	ANALYSIS(52412-300) , MANUFACTURE(52412-300) , PACK(52412-300) , LABEL(52412-300)

Revised: 4/2019

Document Id: a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a

Set id: 77ab634e-13d4-4f5f-87c8-73976e65a842

Version: 3

Effective Time: 20190412