FIRE OUT- benzocaine and menthol solution

Fire Out by

Drug Labeling and Warnings

Fire Out by is a Otc medication manufactured, distributed, or labeled by Randob Ltd., Multi-Pack Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/15/2016

Labeler - Randob Ltd. (061995007)

Registrant - Randob Ltd. (061995007)

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