Label: ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH- sodium fluoride rinse
- NDC Code(s): 41167-0964-1, 41167-0964-4
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 20, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigorously swish 10 milliliters 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
- use twice a day after brushing your teeth with a toothpaste
- Other information
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Inactive ingredients
water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, bisabolol, carnosine, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, PEG-14M, PEG-160M, flavors, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (283-180)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0964 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.09 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) POLOXAMER 407 (UNII: TUF2IVW3M2) BETAINE (UNII: 3SCV180C9W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LEVOMENOL (UNII: 24WE03BX2T) CARNOSINE (UNII: 8HO6PVN24W) GINGER (UNII: C5529G5JPQ) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) POLYETHYLENE GLYCOL 600000 (UNII: 2126FD486L) POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM PHOSPHATE (UNII: SE337SVY37) POLYSORBATE 20 (UNII: 7T1F30V5YH) LACTIC ACID (UNII: 33X04XA5AT) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0964-1 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2012 2 NDC:41167-0964-4 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2012 04/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/01/2012 Labeler - Chattem, Inc. (003336013)
