OTC Medication Information: Crest Pro Health

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:

Label8
(click image for full-size original)

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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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