KILLFIRE MOUTHWASH- sodium fluoride rinse

Killfire Mouthwash by

Drug Labeling and Warnings

Killfire Mouthwash by is a Otc medication manufactured, distributed, or labeled by Pharmacal-International. Co., Ltd., Ecoworld Co .,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride (0.02%)

Purpose

• Anticavity mouthwash

Use

• Aids in prevention of dental cavities

Directions

• Rinse mouth with this Killfire Mouthwash about 10~15ml for 30 seconds then expel

Average daily dose

•  Use twice a day after brushing, meals, and before social occasions.

Warnings

• Keep out of reach of children.
• Children under 7 years or younger must have parent supervision.
• Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Inactive Ingredients

Sodium Fluoride, Allantoin, Glycerin, Xylitol, Acetic acid, Sodium acetate, Malic acid, Sodium Benzoate, GreenTea Extract, Sodium Saccharin, flavoring, Polyoxyethylenehardened castor oil, L-Menthol, Cacao Color, Purified water

Product label

INGREDIENTS AND APPEARANCE

KILLFIRE MOUTHWASH 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-132
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
ACETIC ACID (UNII: Q40Q9N063P)
SODIUM ACETATE (UNII: 4550K0SC9B)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
RACEMENTHOL (UNII: YS08XHA860)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-132-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/25/2021

Labeler - Pharmacal-International. Co., Ltd. (557805060)

Registrant - Pharmacal-International. Co., Ltd. (557805060)

Establishment
Name	Address	ID/FEI	Business Operations
Ecoworld Co .,ltd		688735061	manufacture(24765-132)