Label: AQUAFRESH SENSITIVE MAXIMUM STRENGTH- potassium nitrate and sodium fluoride paste
- NDC Code(s): 0135-0605-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 19, 2023
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- Active ingredients
Stop use and ask a dentist if
- the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
- pain/sensitivity still persists after 4 weeks of use.
adults and children 12 years of age and older:
- apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
- brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
DENTIST RECOMMENDED ACTIVE INGREDIENTS
maximum strength* sensitive
Sugar Acid Protection**
- healthy gums†
- strong teeth
- fresh breath
NET WT 5.6 OZ (158.8 g)
Aquafresh® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.
targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity
†with twice daily brushing
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed of the GSK group of companies.
GSK Consumer Healthcare Warren, NJ 07059
*maximum FDA sensitivity active ingredient
©2015 GSK or its licensor.
INGREDIENTS AND APPEARANCE
AQUAFRESH SENSITIVE MAXIMUM STRENGTH
potassium nitrate and sodium fluoride paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0605 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor MINT (smooth mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0605-01 1 in 1 CARTON 02/17/2017 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 not final part356 02/17/2017 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)