Doctor EL 28 Care Gargle by Dr. EL CO., LTD. / BIOSTECH CO., LTD.

Doctor EL 28 Care Gargle by

Drug Labeling and Warnings

Doctor EL 28 Care Gargle by is a Otc medication manufactured, distributed, or labeled by Dr. EL CO., LTD., BIOSTECH CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCTOR EL 28 CARE GARGLE- sodium fluoride, tocopherol acetate liquid 
Dr. EL CO., LTD.

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.

----------

Sodium Fluoride

For dental care

Keep out of reach of children

Gargle for 30-45 seconds with 10mL (about 1 capful) making sure it comes in to contact with all areas of the teeth. Spit out mouthwash.

Don’t swallow.

In case of accidental ingestion, seek professional assistance.

Keep out of a reach of children.

Consult with a dentist or doctor for use with children under 6 years of age.wallowed, get medical help or contact a Poison Control Center right away

Water, Ethanol, Glycerin, PEG-40 Hydrogenated Castor Oil, Poloxamer 407, Sodium Citrate, Citric Acid, Xylitol, Menthol, Sodium Saccharin, Sucralose, Allantoin, Mentha Piperita Oil, Flavor, Glycyrrhiza Uralensis Extract, Angelica Gigas Extract, Salvia Officinalis Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Calendula Officinalis Flower Extract, Propolis Extract

For dental use only

DOCTOR EL 28 CARE GARGLE 
sodium fluoride, tocopherol acetate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-111
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72440-111-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/2020	05/01/2022

Labeler - Dr. EL CO., LTD. (694771074)

Registrant - Dr. EL CO., LTD. (694771074)

Establishment
Name	Address	ID/FEI	Business Operations
BIOSTECH CO., LTD.		687294330	manufacture(72440-111)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-111)

Revised: 5/2022

Document Id: de261019-132e-609a-e053-2a95a90a4704

34390-5

Set id: a981dd1a-17f0-34d2-e053-2a95a90a0219

Version: 2

Effective Time: 20220503