Alcohol Free Antiseptic: Package Insert and Label Information

ALCOHOL FREE ANTISEPTIC- cetylpyridinium chloride mouthwash
Rite Aid

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.

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque {bacteria} that leads to gingivitis

Warnings

for this product

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 of 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 20 mL (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 consult a dentist or doctor

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

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

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse – Refreshing Clean Mint

Disclaimer

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE: If you’re not satisfied, we’ll happily refund your money

principal display panel

Sealed with printed neckband for your protection

Compare to Crest Pro-Health

Multi-Protection

Alcohol Free Rinse

Refreshing Clean Mint

MULTI-ACTION

ALCOHOL FREE

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE RINSE

FRESH MINT

kills germs

helps prevent plaque & gingivitis

helps keep teeth feeling clean

freshens breath

no burn of alcohol

RITE

AID

PHARMACY

1L (33.8 FL OZ)

image description
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ALCOHOL FREE ANTISEPTIC
cetylpyridinium chloride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5761
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
GLYCERIN
POLOXAMER 188
SACCHARIN SODIUM
PROPYLENE GLYCOL
SODIUM BENZOATE
SUCRALOSE
BENZOIC ACID
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-5761-2 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/16/2019
Labeler — Rite Aid (014578892)
Registrant — Vi-Jon, Inc (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, Inc 088520668 manufacture (11822-5761)

Revised: 01/2020 Rite Aid

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