Label: CLOSYS- hydrogen peroxide rinse
- NDC Code(s): 58578-0613-1
- Packager: Rowpar Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2025
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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KEEP OUT OF REACH OF CHILDREN
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 doctor if
- sore mouth symptoms do not improve within 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.
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Directions
Adults and children 12 years of age and older
- Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
Children 6 years to under 12 years of age: supervise use
Children under 6 years of age: do not use
- Other Information
- Inactive ingredients
- Questions or comments?
- QUESTIONS
- SPL UNCLASSIFIED SECTION
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Packaging
A CLEANER MOUTH
A HEALTHIER YOU®
CLoSYS®
Oral Debriding Agent
MOUTH
SORES
SENSITIVE
MOUTH RINSE
PROMOTES HEALING
HELPS CLEANSE & PROMOTE HEALING OF
ORAL SORES, MOUTH BURNS & IRRITATION
For Canker Sores, Cheek Bites,
Irritation from Dentures or Braces,
Gum Irritation
Non Burning, Alcohol-Free
Formula
Gentle Mint
16 fl oz (473mL)
52516-75Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807
1 (800) 643-3337 closys.com
52516-76
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INGREDIENTS AND APPEARANCE
CLOSYS
hydrogen peroxide rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58578-0613 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Polysorbate 20 (UNII: 7T1F30V5YH) Polysorbate 80 (UNII: 6OZP39ZG8H) Sucralose (UNII: 96K6UQ3ZD4) Edetate Disodium (UNII: 7FLD91C86K) Menthol, Unspecified Form (UNII: L7T10EIP3A) Citric Acid Monohydrate (UNII: 2968PHW8QP) Product Characteristics Color Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58578-0613-1 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/27/2025 Labeler - Rowpar Pharmaceuticals, Inc. (783704661)