Colgate® Dry Mouth Relief

Drug Labeling and Warnings

Drug Details [pdf]

COLGATE DRY MOUTH RELIEF- sodium fluoride rinse 
Colgate Oral Pharmaceuticals, 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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0126-0021
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.1 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BETAINE (UNII: 3SCV180C9W)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0126-0021-03	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2011	06/30/2019
2	NDC: 0126-0021-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2011	06/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/14/2011	06/30/2019

Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019

Document Id: 283e68a5-2bee-4b77-b34e-38c440668819

34390-5

Set id: 5bd056bf-b43b-4b7a-8f11-5efe8bd81136

Version: 2

Effective Time: 20190905