Antiseptic Mouthwash
FDA Label NDC 11673-299

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Antiseptic (NDC 11673-299). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding claims, active ingredient, purpose, use, warnings for this product, stop use and ask a dentist if, keep out of reach of children under 6 years of age, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Claims

Use Up & Up alcohol free antiseptic mouth rinse for better oral hygiene and fresher breath.

Active Ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings For This Product

Warnings

Stop Use And Ask A Dentist If

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease

Keep Out Of Reach Of Children Under 6 Years Of Age

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 years & older: rinse for 30 seconds with 20mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other Information

  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Questions

Call 1-800-910-6874

Safety Information

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent occurence.

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Rinse

Adverse Reactions

Dist. by Target Corp.

Mpls., MN 55403

Made in U.S.A. from U.S. and foreign components

Shop Target.com

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multi-action

alcohol-free antiseptic

mouth rinse

CPC antigingivitis/antiplaque

Compare to active ingredient in

Crest Pro-Health Rinse

helps prevent and reduce plaque and gingivitis

helps remove germs that cause bad breath

up & up

Fresh Mint Flavor

50.7 FL OZ

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Image Description (Mm3)

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