PCXX NAF RNS MINT- sodium fluoirde rinse 
Ross Healthcare 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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PCxx NaF RNS Mint

Adults and children 6 years of age and older:

use once a day after brushing your teeth with a toothpaste
remove cap
hold bottle upright and squeeze. Fill to FILL LINE
pour out. Only the correct 10 milliliters dose will pour out
vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision

children under 6 years of age: consult a dentist or doctor.

Keep out of reach of children.

If more than used for rinsing is accidently swallowed, get medical help or contact Poison Control Center right away.

potassium sorbate, xylitol, sucralose, water

Aids in the prevention of dental cavities

Sodium Fluoride 0.05%

Anticavity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCXX NAF RNS MINT 
sodium fluoirde rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62007-400
Route of AdministrationTOPICAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.04 mg  in 1 mL
XYLITOL (UNII: VCQ006KQ1E) 0.5 mg  in 1 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 0.01 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-400-161 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/22/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/22/2017
Labeler - Ross Healthcare Inc. (244249012)

Revised: 11/2017
Document Id: 5e95fcb1-0e78-b35e-e053-2a91aa0a20a7
Set id: 5e95fcb1-0e77-b35e-e053-2a91aa0a20a7
Version: 1
Effective Time: 20171122
 
Ross Healthcare Inc.