SODIUM FLUORIDE- clear mint, gel toothpaste gel 
Dynarex Corporation

----------

5900 Clear Mint, Gel Toothpaste, 0.6oz.
5901 Clear Mint, Gel Toothpaste, 4.6oz.
5902 Glear Mint, Gel Toothpaste, 1.5oz.
5903 Clear Mint, Gel Toothpaste, 0.85oz

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use(s)

Helps protect against cavities

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Ask a dentist or physician.

Inactive Ingredients

Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Other Information

Store between 15º-35ºC (59º-95ºF)

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label 5900

5900_BX_MASTER5900 Clear Mint, Gel Toothpaste

Label 5901

5901_BX_MASTER5901 Clear Mint, Gel Toothpaste

Label 5902

5902_IN_MASTER5902 Clear Mint, Gel Toothpaste

Label 5903

5903_BX_MASTER5903 Clear Mint, Gel Toothpaste

SODIUM FLUORIDE 
clear mint, gel toothpaste gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-180
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION220 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-180-03720 in 1 CASE07/16/2024
1NDC:67777-180-02144 in 1 BOX
1NDC:67777-180-0117 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67777-180-0660 in 1 CASE07/16/2024
2NDC:67777-180-051 in 1 BOX
2NDC:67777-180-04130 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:67777-180-08144 in 1 CASE07/16/2024
3NDC:67777-180-0742.5 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:67777-180-11720 in 1 CASE07/16/2024
4NDC:67777-180-10144 in 1 BOX
4NDC:67777-180-0924 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/16/2024
Labeler - Dynarex Corporation (008124539)

Revised: 6/2024
Document Id: 1be193b6-4c08-4f0a-e063-6394a90a32c7
Set id: 1be193b6-4c07-4f0a-e063-6394a90a32c7
Version: 1
Effective Time: 20240627
 
Dynarex Corporation