PUREOXYWASH- hydrogen peroxide 3% baking soda 
PureOxyWash Inc

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.

----------

Elimination Wash -

Adults and children 6 years of age and older perform the following steps twice a day, morning and evening (flossing can be done once a day)

- floss

- brush teeth

- scrape tongue using tongue scraper or toothbrush, scrape in a back to forward motion starting all the way from the back of your tongue

- pour out a half an ounce (3spn, 1tbsp) and add an equal amount of water to it and then mix it up

- swish and gargle * for 2 minutes

- spit out and rinse mouth with water

- perform the Prevention Wash

*when gargling, tilt your head back, and stick out your tongue

Prevention Wash -

Adults and chiildren 6 years of age and older perform the following steps twice a day, morning and evening after the use of the Elimination Wash

- flip bottle upside down and shake well for 10-20 seconds (first time use, take safety seal off, shake vigorously for about a minute until is fluid and ready to go)

- immediately pour out a half an ounce (3tspn, 1tbsp) and mix it up

- swish and gargle * for 2 minutes

- spit out and rinse mouth with water

* when gargling, tilt your head back, and stick out your tongue.

Keep out of reach of children, if accidentally swallowed, get medical hep or contact a Poison Control Center right a way.

Elimination Wash

- Water

Prevention Wash

- Water, Sodium, Phosphate, Chlorine, Fluoride

Elimination Wash

- dont shake bottle

- keep tightly closed

- store in room temperature

- do not use if safety seal is broken or missing

- keep in a dark place

- hold away from face when opening

- children under 12 years of age should be supervised when using this product

Use - helps to eliminate halitosis causing bacteria

Prevention Wash

- store in room temperature, avoid storing in cold area

- do not use if safety seal is broken or missing

- children under 12 years of age should be supervised when using this product

- when using the Prevention Wash for the first time, take safety seal out, flip bottle upside down and shake vigorously for about a minute until content is fluid and ready to go. Also do this when you havent used the Prevention Wash in a while. If you feel its needed to be, take the cap off to release pressure and put the cap back on to start shaking again.

- If the Prevention Wash becomes too thick, add a little water to it, to make it more fluid.

Use - helps to lower adicity

Elimination Wash

- Anti Bacterial

Prevention Wash

- Pro Alkaline

keep out of reach of children, if accidentally swallowed, get medical help or contact a Poison Control Center right away

Elimination Wash

- Dihydrogen Dioxide (hydrogen peroxide 3%)

Prevention Wash

- Sodium Hydrogencarbonate (baking soda)

PureOxyWash Elimination Wash Label

PureOxyWash Prevention Wash Label

PUREOXYWASH 
hydrogen peroxide 3% baking soda kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70971-3456
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70971-3456-12 in 1 PACKAGE03/24/201308/21/2018
11 in 1 KIT; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 1006 mL
Part 20 BOTTLE 1 mL
Part 1 of 2
PUREOXYWASH 
hydrogen peroxide 3% mouthwash
Product Information
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11006 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/24/201308/21/2018
Part 2 of 2
PUREOXYWASH 
hydrogen peroxide, sodium bicarbonate mouthwash
Product Information
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE742.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1916 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/24/201308/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/24/201308/21/2018
Labeler - PureOxyWash Inc (079646333)
Establishment
NameAddressID/FEIBusiness Operations
PureOxyWash Inc079646333manufacture(70971-3456)

Revised: 12/2018
 
PureOxyWash Inc