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Colgate

Colgate Oral Pharmaceuticals, Inc.

Colgate Dry Mouth Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Colgate 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

Colgate

SODIUM FLUORIDE RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0126-0021
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.1 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0126-0021-03 59 in 1 BOTTLE
2 NDC:0126-0021-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-01-14


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