Crest Pro Health: Package Insert and Label Information

CREST PRO HEALTH- cetylpyridinium chloride rinse
Navajo Manufacturing Company Inc.

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 Facts

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

_{Antigingivitis/antiplaque}

Uses

• helps prevent/reduce plaque and gingivitis
• helps control plaque bacteria that contibute to the development of gingivitis/bleeding gums

Warnings

Ask a dentist if

symptoms persist or condition worsens after regular use.

Keep out of reach of children.

under 6 yrs. of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use after your normal brushing and flossing routine; toothpaste from mouth prior to use
• adults and children 6 yrs. & older: Rinse for 30 seconds with 20 ml (4 teaspoonfuls) twice a day
• do not swallow
• children 6 to 12 yrs. of age: supervise use
• children under 6 yrs. of age: do not use

Inactive ingredients

water, glycerin, flavor, poloxamer 407, sodium saccharin, methylparaben, sucralose, propylparaben, blue 1

Questions or comments?

1-800-285-9139

Package Labeling:

CREST PRO HEALTH cetylpyridinium chloride rinse

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-186(NDC:37000-451) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.014 g in 20 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN METHYL SALICYLATE POLOXAMER 407 SACCHARIN SODIUM METHYLPARABEN SUCRALOSE PROPYLPARABEN FD&C BLUE NO. 1

Product Characteristics Color blue Score Shape Size Flavor WINTERGREEN Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67751-186-01 36 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 12/04/2017

Labeler — Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Operations
Navajo Manufacturing Company Inc.		136941411	relabel (67751-186), repack (67751-186)

Revised: 03/2023 Navajo Manufacturing Company Inc.