Active Ingredient
Benzocaine USP 20%
Menthol USP 1%
Fire Out Solution
FDA Label NDC 52412-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Randob Ltd. for the product Fire Out (NDC 52412-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Carton-label-bottle (Image 01)
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