ORABALANCE DENTALCARE- lactobacillus gasseri hhumin, lactobacillus fermentum ok tablet

OraBalance dentalcare by

Drug Labeling and Warnings

OraBalance dentalcare by is a Otc medication manufactured, distributed, or labeled by isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Lactobacillus gasseri HHuMin

Lactobacillus fermentum OK

Purpose

Eliminate Bad Breath

use

Improve oral health care

Warnings

do not eat silica gel

Warnings

be careful, as you may get hurt when opening it.

Warnings

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

avoid direct sunlight and store it in a dry, ventilated, cool place.

Warnings

Keep out of reach of children

Directions

Melt one tablet slowly in your mouth and eat once

Inactive Ingredients

Oligosaccharide 3(Palatinos, Maltitol Syrup, Galacto-oligosaccharide)
xylitol
isomalt
maltodextrin
grape flavor powder
vitamin C
Magnesium Stearate
Calcium Pantothenate
silicon dioxide
vitamin E
vitamin K2
collagen

PACKAGE LABEL

82690-401
OraBalance Dentalcare

INGREDIENTS AND APPEARANCE

ORABALANCE DENTALCARE 
lactobacillus gasseri hhumin, lactobacillus fermentum ok tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82690-401
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS GASSERI (UNII: Q66E0D2443) (LACTOBACILLUS GASSERI - UNII:Q66E0D2443)	LACTOBACILLUS GASSERI	24 mg  in 100 g
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP)	LIMOSILACTOBACILLUS FERMENTUM	72 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENAQUINONE 6 (UNII: 71ANL51TLA)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
CITRUS PARADISI WHOLE (UNII: 3FNT9K2294)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ISOMALTULOSE ANHYDROUS (UNII: V59P50X4UY)
4'-GALACTOSYLLACTOSE (UNII: B8CW1B3F6R)
MALTITOL (UNII: D65DG142WK)
XYLITOL (UNII: VCQ006KQ1E)
ISOMALT (UNII: S870P55O2W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	SPEARMINT	Imprint Code	blank
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82690-401-01	24 g in 1 BOX; Type 0: Not a Combination Product	07/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/13/2022

Labeler - isamogu Inc. (695695834)