Description
Rx ONLY
2.7% Neutral Sodium Fluoride
IMPROVES INTERPROXIMAL REDUCTION
Eversmile Ipr Glide Gel
FDA Label NDC 72655-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everbrands, Inc. Dba Everpure, Inc. for the product Eversmile Ipr Glide (NDC 72655-400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, how supplied, directions, precautions/warnings, indications, active ingredients, inactive ingredients, ipr glide™ labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
How Supplied
4mL in plastic syringe. Mint: NDC 72655-400-01
1mL in plastic syringe. Mint: NDC 72655-400-02
Directions
Directions For Use:
IPR procedure: Dispense IPR Glide directly to the
interproximal tooth surfaces or to IPR cutting
instruments. Perform IPR procedure and replenish
IPR Glide as needed. Rinse teeth with water. Inform
patient not to swallow IPR Glide.
In-Office Post IPR Renewal: Rinse teeth with water,
air dry and apply IPR Glide directly to teeth surfaces
where IPR was performed. Have patient spit out
excess IPR Glide and inform patient to keep surfaces
dry for 30 minutes avoiding food and liquids. Aligners
may be worn to prevent saliva contamination.
At-home Post IPR Renewal: Apply IPR Glide inside
of aligners at the location where IPR was performed.
Your dentist can use a marker and indicate where to
apply the IPR Glide. Place aligners in mouth and wipe
off any excess IPR Glide using a tissue. Allow IPR Glide
to remain on teeth for 5-10 minutes, then remove
aligners and spit out any excess. Keep surfaces dry
for 30 minutes avoiding food and liquids.
Precautions/Warnings
Precautions/Warnings:
Store above 25°C/77°F.
Keep out of reach of
children. Read directions
carefully before using.
Do not swallow. If a large dose is ingested (more than
1/4 oz), contact poison control and seek medical help
immediately. Do not use if nursing, pregnant, or allergic
to fluoride or any listed inactive ingredient.
Indications
Indications: To prevent dental
caries and strengthen enamel.
Active Ingredients
Active Ingredients: 2.7% Sodium Fluoride (1.23% w/w fluoride ion)
Inactive Ingredients
Inactive Ingredients:
Water, glycerin, hydroxyethyl
cellulose, propylene glycol,
sucralose, mint oil, sodium
benzoate, propylparaben.
Ipr Glide™ Labeling
-----------------------------------------------------
DURING AND AFTER
IPR GLIDE™
LUBRICATES & STRENGTHENS ENAMEL
Rx ONLY
2.7% Neutral Sodium Fluoride
4ml (0.13 fl oz)
Manufactured By
EverBrands, Inc.
11791 Monarch St
Garden Grove,
CA 92841
iprglide.com
eversmilewhite.com
(855) 595-2999
[email protected]
4mL
1mL
res
* Please review the disclaimer below.
