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
Drug Label Information
Updated March 24, 2025
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- Official Label (Printer Friendly)
- Inactive Ingredients
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- 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 DENTAL 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 Drug M022 05/26/2021 PRO-SYS
oral wound cleanser liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70275-201 Route of Administration DENTAL 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 Drug M022 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)