Lab 52 Essential Oil Sensitive by TOOTHFILM INC Marketing End 003

Lab 52 Essential Oil Sensitive by

Drug Labeling and Warnings

Lab 52 Essential Oil Sensitive by is a Otc medication manufactured, distributed, or labeled by TOOTHFILM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAB 52 ESSENTIAL OIL SENSITIVE- potassium citrate, sodium fluoride paste, dentifrice 
TOOTHFILM INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Marketing End 003

Lab52 Essential Oil Sensitive Toothpaste

Potassium Citrate 5.53%，Sodium Fluoride 0.32%

Glycerin, Water, Silica, Sodium Lauroyl Sarcosinate, Polysorbate 80, Isomaltitol, Calcium Lactate, Eucalyptus Globulus Leaf Oil, Menthol, Cellulose Gum, Dicalcium Phosphate, Citrus Aurantium Dulcis (Orange) Oil, Potassium Acesulfame, Titanium Dioxide, Mentha Arvensis Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Allantoin, Dipotassium Glycyrrhizinate, Calcium Oxide

Squeeze out an appropriate amount and clean your mouth with correct brushing habits, at least 2 times a day, at least 2-3 minutes each time

If you feel uncomfortable after using the product, please stop using it immediately and consult a professional doctor for assistance

For sensitive tooth pain, protect teeth

Please keep out of reach of children
Prohibited for use by children

Reduce sensitive tooth pain

Store in a cool and ventilated place, avoid direct sunlight and high temperature, the shelf life is 3 years

LAB 52 ESSENTIAL OIL SENSITIVE 
potassium citrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82711-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	POTASSIUM CITRATE	5.53 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.32 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MENTHOL (UNII: L7T10EIP3A)
ORANGE OIL (UNII: AKN3KSD11B)
CALCIUM LACTATE (UNII: 2URQ2N32W3)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CLOVE OIL (UNII: 578389D6D0)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
ISOMALTITOL (UNII: QFA026JZX2)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SPEARMINT OIL (UNII: C3M81465G5)
ALLANTOIN (UNII: 344S277G0Z)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82711-003-01	80 g in 1 BAG; Type 0: Not a Combination Product	05/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/07/2022	05/01/2023

Labeler - TOOTHFILM INC (656036549)

Establishment
Name	Address	ID/FEI	Business Operations
TOOTHFILM INC		656036549	manufacture(82711-003)

Revised: 9/2023

Document Id: 063f2eaa-b633-e73f-e063-6294a90aa075

34390-5

Set id: de6485bc-35b2-539b-e053-2995a90ab28d

Version: 2

Effective Time: 20230926