NDC 70275-937 Oxistom

Oral Wound Cleanser

NDC Product Code 70275-937

NDC 70275-937-13

Package Description: 400 mL in 1 BOTTLE

NDC Product Information

Oxistom with NDC 70275-937 is a a human over the counter drug product labeled by Forward Science Technologies Llc. The generic name of Oxistom is oral wound cleanser. The product's dosage form is liquid and is administered via buccal form.

Labeler Name: Forward Science Technologies Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Oxistom Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROGEN PEROXIDE 15 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • XYLITOL (UNII: VCQ006KQ1E)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Buccal - Administration directed toward the cheek, generally from within the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Forward Science Technologies Llc
Labeler Code: 70275
FDA Application Number: part356 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-26-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Oxistom Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Inactive Ingredients

Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol

Questions?

1-855-696-7254

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Purpose

Oral Debriding Agent / Oral Wound Cleanser

Other Information

Store at controlled room temperatures 68 - 77ºF (20 - 25ºC) and away from direct sunlight. Keep cap tightly closed when not in use.

Uses

• Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

• For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

• For temporary use to cleanse canker sores.

• Assists in the removal of foreign material from minor oral wounds.

Warnings

Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow.

Stop use and ask a dentist or physician if:
• sore mouth symptoms do not improve in 7 days;

• irritation, pain, or redness persists or worsens;

• swelling, rash, or fever develops.

Keep Out Of Reach Of Children

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

Directions

• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.

• Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.

• Children under 12 years of age should be supervised in the use of the product.

• Children under 2 years of age: Consult a dentist or physician.

• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.

• Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.

• Children under 12 years of age should be supervised in the use of the product.

• Children under 2 years of age: Consult a dentist or physician.

* Please review the disclaimer below.