Label: AQUAFRESH EXTREME CLEAN PURE BREATH ACTION- sodium fluoride paste
- NDC Code(s): 0135-0604-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
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- Active ingredient
- Purpose
- Use
- Warnings
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Directions
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adults and children 2 years of age and older:
- apply toothpaste onto a toothbrush
- brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
- to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
- children under 2 years of age:consult a dentist or doctor.
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adults and children 2 years of age and older:
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 0135-0604-01
Aquafresh ®
triple protection®
fluoride toothpaste
pure breath action
Sugar Acid Protection**
from Fluoride
EXTREME CLEAN ®
WITH MICRO-ACTIVE FOAMING ACTION + WHITENING
for 80% cleaner, purer breath*
NET WT 5.6 OZ (158.8g )
fresh mint
Aquafresh ®Extreme Clean ®Pure Breath Action toothpaste creates micro-active foam which seeks out hard to reach places and rinses clear to leave your teeth clean and smooth. It neutralizes bad breath odors for 80% cleaner, purer breath.* Take the Feeling of Clean to the Extreme! ®
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.
triple protection®
- healthy gums†
- strong teeth
- fresh breath
†with twice daily brushing
*immediately after brushing versus a zinc free toothpaste
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2015 GSK group of companies or its licensor. All rights reserved.
GSKConsumer Healthcare
Warren, NJ 07059
1-800-897-5623
105483XA
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INGREDIENTS AND APPEARANCE
AQUAFRESH EXTREME CLEAN PURE BREATH ACTION
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0604 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ZINC CHLORIDE (UNII: 86Q357L16B) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor MINT (fresh mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0604-01 1 in 1 CARTON 06/01/2016 1 158.8 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 06/01/2016 Labeler - Haleon US Holdings LLC (079944263)