Label: CPH ANTI-BACTERIAL BREATH MIST- cetylpyridinium chloride spray
- NDC Code(s): 63645-179-06
- Packager: OraLabs
- 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 April 18, 2022
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- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
For external use only:
Do not use this product if gums are irritated or bleeding unless directed to do by a doctor or dentist. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. Do not spray into the eyes. If spray gets into the eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.
- Directions
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
CPH ANTI-BACTERIAL BREATH MIST
cetylpyridinium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63645-179 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 1.11 g in 13.0 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 11.18 mL in 13.0 mL HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 1.3 mL in 13.0 mL MENTHOL, (+)- (UNII: C6B1OE8P3W) .0065 mL in 13.0 mL SUCRALOSE (UNII: 96K6UQ3ZD4) .039 mL in 13.0 mL Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63645-179-06 13.0 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/15/2022 Labeler - OraLabs (801824756) Registrant - OraLabs (801824756) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 MANUFACTURE(63645-179) , LABEL(63645-179)
