MORNING FRESH- sodium fluoride paste 
Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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4872 Morning Fresh Toothpaste NDC 67777-175-01
4873 Morning Fresh Toothpaste NDC 67777-175-02

Active Ingredient

Sodium Monofluorophosphate 0.76 %

Purpose: Anticavity

Use

Inactive Ingredient

Calcium carbonate, Carboxymethylcellulose sodium, Flavour, Methylparaben, Polyethyene glycol 400, Propylparaben, Saccharin sodium, Silicon dioxide, Sodium benzoate, Sodium lauryl sulphate, Sodium pyrophosphate, Sodium silicate, Sorbitol, Titanium dioxide, Water

Dosage and Administration

Directions:

Indications and Usage

Warnings

Keep out of reach of children.

Keep out of reach of children under 6 years of age.

Principal Display Panel

Dynarex Morning Fresh Toothpaste

Morning Fresh.jpg

Morning Fresh

MORNING FRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-175
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION76 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SILICATE (UNII: IJF18F77L3)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-175-11144 in 1 CASE10/14/2014
1NDC:67777-175-101 in 1 BOX
1NDC:67777-175-0143 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67777-175-13144 in 1 CASE10/14/2014
2NDC:67777-175-121 in 1 BOX
2NDC:67777-175-0278 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/14/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 12/2022
Document Id: eec81c4c-972d-722f-e053-2995a90aeccd
Set id: 1d0457d7-0228-4ea3-9755-73bacd2201e6
Version: 4
Effective Time: 20221201
 
Dynarex Corporation