Label: EVERSMILE ALIGNERFRESH ENAMEL GUARD- sodium fluoride rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 72655-300-01 - Packager: Everbrands, Inc.
- 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.
Drug Label Information
Updated March 29, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
Tray application
- Adults and children 12 yrs. of age and older:
- Dispense up to a full pump of foam inside each tray.
- Use the nozzle tip to cover all areas of the tray evenly with foam.
- Place form-filled trays back in mouth.
- Spit out excess.
- No need to rinse as foam naturally dissipates.
- Do not swallow rinse.
- Children under 12 years of age: consult a dentist or doctor.
To rinse:
- Adults and children 12 years & older:
- Use twice a day after brushing your teeth with a toothpaste.
- Vigorously swish 2 pumps 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 12 years of age: consult a dentist or doctor.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Package Label
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INGREDIENTS AND APPEARANCE
EVERSMILE ALIGNERFRESH ENAMEL GUARD
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72655-300 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.225 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETIDRONIC ACID (UNII: M2F465ROXU) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) POVIDONE K30 (UNII: U725QWY32X) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72655-300-01 1 in 1 PACKAGE 02/16/2022 1 50 mL in 1 BOTTLE, PUMP; 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 02/16/2022 Labeler - Everbrands, Inc. (080314845) Registrant - Everbrands, Inc. (080314845) Establishment Name Address ID/FEI Business Operations Everbrands, Inc. 080314845 manufacture(72655-300)
