FDA Label for Fire Out
View Indications, Usage & Precautions
Fire Out Product Label
The following document was submitted to the FDA by the labeler of this product Randob Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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▪ Clean area▪ Apply to affected area as needed not more than 3 to 4 times a day.
Adults and children 2 yrs. and older
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:
MAXIMUM STRENGTH
PAIN RELIEVING LIQUID
NO-MESS ROLL-ON
1.7 fl oz (50 ml)
MADE IN THE USA
DUAL ACTION
* Please review the disclaimer below.