FIRE OUT- benzocaine and menthol solution 
Randob Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

carton-label-bottle
FIRE OUT 
benzocaine and menthol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (Blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-300-101 in 1 CARTON02/15/2016
150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:52412-300-205 in 1 BLISTER PACK03/15/201703/15/2017
20.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2016
Labeler - Randob Ltd. (061995007)
Registrant - Randob Ltd. (061995007)
Establishment
NameAddressID/FEIBusiness Operations
Multi-Pack Solutions557434805ANALYSIS(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
 
Randob Ltd.