KILL FIRETOOTHPASTE- sodium fluoride paste 
Pharmacal-International. Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Active ingredient

Sodium Fluoride 0.02%

Purpose

  • Anticavity Toothpaste

Use

  • Aids in the prevention of dental cavities

Directions

  • Apply appropriate amount on a toothbrush and brush teeth.

Warnings

  • Be careful not to swallow. Rinse mouth thoroughly after use.
  • If pain occurs when using this product, stop using and consult your dentist.
  • For children under 6 years of age, use a pea size amount of toothpaste as recommended by the KFDA. Use under the guidance of a guardian.
  • If a child under 6 years old swallows a large amount, consult a physician or dentist immediately.
  • Keep out of the reach of children under 6 years old.

Inactive ingredients

Silica,Sorbitol, Tetrasodium Pyrophosphate, Tocopheryl Acetate,
Xylitol, Glucosyl Stevioside, Hydrated Silica, Cellulose Gum, Sodium lauryl Sulfate, Menthol,
Chamomilla Recutita (Matricaria) Extract, Artemisia Princeps Extract, Zingiber Officinale (Ginger) Root Extract,
Melaleuca Alternifolia (Tea Tree) Leaf Oil, Flavor, Gardenia Red, Water

Effect- Efficacy

  • Whitens teeth while fighting germs
  • Long-lasting freshness and clean mouth feel
  • Protects against cavities and bad breath
  • Natural brightness of your teeth shines
  • Anti plaque
  • Helps prevent plaque, gingivitis cavities and gum disease

Product label

image descriptionimage description

KILL FIRETOOTHPASTE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
GINGER (UNII: C5529G5JPQ)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24765-133-01100 g in 1 TUBE; Type 0: Not a Combination Product06/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2021
Labeler - Pharmacal-International. Co., Ltd. (557805060)
Registrant - Pharmacal-International. Co., Ltd. (557805060)
Establishment
NameAddressID/FEIBusiness Operations
KMPHARMACEUTICAL Co.,Ltd.689850153manufacture(24765-133)

Revised: 8/2023
Document Id: 03243f48-b5e4-c0bb-e063-6394a90a3157
Set id: d9609989-2a4a-4357-aea8-44ee95aba524
Version: 5
Effective Time: 20230817
 
Pharmacal-International. Co., Ltd.