Label: COLGATE ENAMEL HEALTH MOUTHWASH- sodium fluoride rinse
- NDC Code(s): 35000-728-16, 35000-728-33, 35000-728-84
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
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
- Other Information
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
NEW
ALCOHOL FREE
Colgate®
Anticavity Fluoride MouthwashENAMEL
HEALTH™STRENGTHENS ENAMEL EVEN
WHERE BRUSHING MAY MISSWITH FLUORIDE
- ✓
-
HELPS REPLENISH NATURAL CALCIUM
BACK INTO ENAMEL - ✓
-
REVERSES ENAMEL SOFTENING TO HELP
PREVENT CAVITIES - ✓
- FRESHENS BREATH
SPARKLING FRESH MINT
33.8 FL OZ
(1.05 QT)
1 LIMPORTANT:
Read directions
for proper useP9903598
-
INGREDIENTS AND APPEARANCE
COLGATE ENAMEL HEALTH MOUTHWASH
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-728 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 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) POLOXAMER 338 (UNII: F75JV2T505) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PHOSPHORIC ACID (UNII: E4GA8884NN) 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:35000-728-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2015 12/30/2024 2 NDC:35000-728-33 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2015 03/31/2026 3 NDC:35000-728-84 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2015 12/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M021 08/01/2015 03/31/2026 Labeler - Colgate-Palmolive Company (001344381)