ETT HOJAKDO SENSITIVITY AND CAVITY CARE- potassium nitrate, sodium fluoride paste, dentifrice

ETT HOJAKDO Sensitivity and Cavity Care by

Drug Labeling and Warnings

ETT HOJAKDO Sensitivity and Cavity Care by is a Otc medication manufactured, distributed, or labeled by LIFE STEALER Co., Ltd., Sejung Medical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

Potassium Nitrate 5%

Sodium Fluoride 0.315%

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Purpose

Antihypersensitivity, Anticavity

Uses

- Builds increasing protection against painful sensitivity of the
teeth to cold, heat, acids, sweets or contact
- Helps protect against cavities

Warnings

Ask a dentist before use if you have
Bleeding or redness lasting more than 2 weeks
Pain, swelling, pus, loose teeth, or more spacing between teeth
These may be signs of periodontitis, a serious form of gum disease

Directions

Supervise children as necessary until capable of using without supervision

Adults and children 12 years of age and older: Brush teeth thoroughly, preferably after each meal or at least 3 minutes twice a day (morning and evening), or as directed by a dentist or a physician

Children under 12 years of age: Consult a dentist or doctor

Inactive Ingredients

Glycerin, Water, Hydrated Silica, Hydroxyapatite, Sorbitol, Cellulose Gum, Sodium Fluoride, Xylitol, Sodium Saccharin, Xanthan Gum, Foeniculum Vulgare Oil, Menthol, Sodium Cocoyl Glutamate, Chamomilla Recutita Flower Extract, Calendula Officinalis Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Stevia Rebaudiana Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETT HOJAKDO SENSITIVITY AND CAVITY CARE 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83672-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.315 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ROSEMARY (UNII: IJ67X351P9)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FOENICULUM VULGARE WHOLE (UNII: J1UK54JBGH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83672-002-02	1 in 1 CARTON	12/11/2024
1	NDC: 83672-002-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/11/2024

Labeler - LIFE STEALER Co., Ltd. (695909253)

Registrant - LIFE STEALER Co., Ltd. (695909253)

Establishment
Name	Address	ID/FEI	Business Operations
Sejung Medical Co., Ltd.		963252282	manufacture(83672-002)