SPL v6
SPL
SPL Set ID 11deebbb-4ad2-4c8b-b1d4-51223284a118
Route
ORAL
Published
Effective Date 2023-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Allantoin Glycerin Xylitol Acetic Acid Sodium Acetate Malic Acid Sodium Benzoate Green Tea Leaf Saccharin Sodium Anhydrous Polyoxyl 35 Castor Oil Racementhol Propolis Wax Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-05-25

Description

Sodium Fluoride (0.02%)

Purpose

Anticavity mouthwash


Medication Information

Purpose
  • Anticavity mouthwash
Description

Sodium Fluoride (0.02%)

Use
  • Aids in prevention of dental cavities
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.
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.
Product Label

Active Ingredient

Sodium Fluoride (0.02%)

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


Structured Label Content

Use
  • Aids in prevention of dental cavities
Purpose
  • Anticavity mouthwash
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.
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.
Product Label (Product label)

Active Ingredient (Active ingredient)

Sodium Fluoride (0.02%)

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


Advanced Ingredient Data


Raw Label Data

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