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Colgate Dry Mouth Relief

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 2.1mg in 10mL
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC Code: 0126-0021

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.

Colgate®
Dry Mouth
Relief

Drug Facts

Active ingredient (in each 10 ml)

Sodium fluoride 2.1 mg

Purpose

Anticavity

Use

aids in the prevention of dental decay

Warnings

Keep out of reach of children. 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 of age and older
  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters (10 ml mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
children under 6 years of age
  • ask a dentist or physician

Other information

store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 407, sodium phosphate, sodium benzoate, betaine, flavor, disodium phosphate, xanthan gum, cellulose gum, carbomer, cetylpyridinium chloride, sodium saccharin, FD&C green no. 3

Questions or comments?

Call toll-free 1-800-962-2345

Colgate Oral
Pharmaceuticals, Inc.
a subsidiary of
Colgate-Palmolive Company
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label

IMPORTANT: Read directions for proper use

Colgate®

Dry Mouth
Relief
Fluoride Mouthwash

ALCOHOL-FREE

Soothing Relief

Formulated for dry mouth sufferers

Moisturizing Mint

P10001727
16 FL OZ (1 PT) 473 ml

COLGATE  DRY MOUTH RELIEF
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0021
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.1 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
SORBITOL 
POLOXAMER 407 
SODIUM PHOSPHATE 
SODIUM BENZOATE 
BETAINE 
SODIUM PHOSPHATE, DIBASIC 
XANTHAN GUM 
CARBOXYMETHYLCELLULOSE SODIUM 
CARBOMER HOMOPOLYMER TYPE A 
CETYLPYRIDINIUM CHLORIDE 
SACCHARIN SODIUM 
FD&C GREEN NO. 3 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0126-0021-0359 mL in 1 BOTTLE
2NDC:0126-0021-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/14/2011
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 07/2011
Document Id: 48d783af-cd13-454c-b061-ea713b967024
Set id: 5bd056bf-b43b-4b7a-8f11-5efe8bd81136
Version: 1
Effective Time: 20110701
 
Colgate Oral Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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