TOTAL DAILY REPAIR- sodium fluoride rinse

Total Daily Repair by

Drug Labeling and Warnings

Total Daily Repair by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

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 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and 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: consult a dentist or doctor

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, sodium saccharin, phosphoric acid, cetylpyridinium chloride, disodium phosphate, potassium sorbate, FD&C blue no. 1

Other information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

NEW

ALCOHOL FREE

Colgate®
Anticavity Fluoride Mouthwash

Total®

DAILY REPAIR
Helps Repair Daily Damage
to Teeth*

WITH FLUORIDE

✓ REFRESHES with a Cool-Clean Formula

✓ RESTORES Natural Calcium

✓ REPAIRS Weakened Enamel

FRESH MINT

33.8 FL OZ
(1.05 QT) 1L

IMPORTANT:
Read directions
for proper use

P9908056

INGREDIENTS AND APPEARANCE

TOTAL DAILY REPAIR 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-391
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 338 (UNII: F75JV2T505)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LEVOMENTHOL (UNII: BZ1R15MTK7)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-391-84	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2015
2	NDC: 35000-391-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2015
3	NDC: 35000-391-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2015
4	NDC: 35000-391-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/07/2015

Labeler - Colgate-Palmolive Company (001344381)