Label: HENRY SCHEIN MOUTH- 1.5% hydrogen peroxide rinse
- NDC Code(s): 0404-0012-01
- Packager: Henry Schein Inc.
- 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 June 30, 2021
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- Active ingredient
- Purpose(s)
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL
Henry Schein® REF 570-2584
MOUTH RINSE
- 1.5% HYDROGEN PEROXIDE
- ALCOHOL FREE
Enjuague bucal
- 1,5 % Peróxido de hidrógeno
- Sin alcohol
Bain de bouche
- 1,5 % De peroxyde d'hydrogène
- Sans alcool
NDC 0404-0012-01
Mint
Menta
Menthe
16 fl. oz.
(473mL)
Distributed by:
HENRY SCHEIN INC.
135 DURYEA ROAD
Melville, NY 11747 USA
MADE IN USA
Rev.2021/05
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INGREDIENTS AND APPEARANCE
HENRY SCHEIN MOUTH
1.5% hydrogen peroxide rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0012 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 mL in 100 mL Inactive Ingredients Ingredient Name Strength SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MENTHOL (UNII: L7T10EIP3A) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) METHYL SALICYLATE (UNII: LAV5U5022Y) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-0012-01 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/30/2021 Labeler - Henry Schein Inc. (012430880)