MINT- sodium monofluorophosphate paste, dentifrice 
Kareway Product, Inc.

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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Pure-Aid Fluoride Toothpaste Fresh Mint

Active ingredient

Sodium Monofluorophosphate 0.76% (0.15%w/v fluoride ion)

Purpose

Anticavity

Usage

helps protect against cavities

Warnings

Enter section text here

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older
brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
Children 2 to 6 years
use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years
ask a dentist or physician

Inactive ingredients

calcium carbonate, sorbitol, water, silicon dioxide, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, methyl parahydroxybenzoate, aminocaproic acid, xylitol, sodium saccharin, DL-menthol, flavor

Enter section text here image of toothpaste carton

MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0111
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
AMINOCAPROIC ACID (UNII: U6F3787206)  
XYLITOL (UNII: VCQ006KQ1E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0111-41 in 1 BOX08/15/2011
1181 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67510-0111-61 in 1 BOX08/15/2011
2170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/15/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4ee88a8-bf3c-454f-e053-2a95a90ae2a1
Set id: 56e93b67-6064-5ae2-e054-00144ff88e88
Version: 3
Effective Time: 20230217
 
Kareway Product, Inc.