Label: OXISTOM- oral wound cleanser liquid
PRO-SYS- oral wound cleanser liquid
- NDC Code(s): 70275-201-16, 70275-201-28, 70275-937-13
- Packager: Forward Science Technologies LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 10, 2023
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- Official Label (Printer Friendly)
- Inactive Ingredients
- Questions?
- Active Ingredient
- Purpose
- Other Information
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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.
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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
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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. -
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. - PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXISTOM
oral wound cleanser liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70275-937 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) METHYL SALICYLATE (UNII: LAV5U5022Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70275-937-13 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/26/2021 PRO-SYS
oral wound cleanser liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70275-201 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) METHYL SALICYLATE (UNII: LAV5U5022Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70275-201-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2022 2 NDC:70275-201-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/16/2022 Labeler - Forward Science Technologies LLC (079212068) Establishment Name Address ID/FEI Business Operations Forward Science Technologies LLC 079212068 manufacture(70275-937, 70275-201)
