FDA.reportPublic FDA data

EACH

Manufacturer
Dongwha Pharm. Co., Ltd.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:21:21

Label at a glance#

ProductEACH
Active ingredientMYRRH
Label structure1 sections

Label contents#

Full prescribing information#

EACH PASTE Gum Care Toothpaste 120g (Original Flavor)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EACH PASTE Gum Care Toothpaste 120g (Original Flavor)EACH PASTE Gum Care Toothpaste 120g (Original Flavor)

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Myrrh tincture 6.2 mg

PURPOSE

OTC - PURPOSE SECTION

Relief of oral discomfort/Astringent

USES

INDICATIONS & USAGE SECTION

♦ helps relief various symptoms caused by gingivitis · pyorrhea alveolaris (redness of gums (redness due to congestion) · swelling · bleeding ·pus etc.)

ASK A DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have ♦receiving other medications ♦severe dry mouth (cuts and sores)

STOP USE

OTC - STOP USE SECTION

Stop use and ask dentist if ♦ you have experience allergic symptoms (rash, redness, itching, etc.) after using this product.
♦ if symptoms do not improve even after using for several days

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS

WARNINGS SECTION

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

♦ for adults, use about 1 gram (3 cm) amount twice a day (morning, evening), massage on gums and brush teeth thoroughly, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
♦ for children: Consult a dentist or doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

♦ carboxymethylcellulose sodium, chamomile tincture, citrus flavor, glycerin, hydrated silica, levomenthol, mint flavor, poliglusam, polyethylene glycol 1600, potassium sorbate, rhatany tincture, saccharin sodium, silicon dioxide, sodium alginate, sodium lauryl sulfate, sorbitol solution, stevioside, titanium dioxide, tribasic calcium phosphate, water, xylitol

OTHER INFORMATION

OTHER SAFETY INFORMATION

♦ store at room temperature between 15ºC ~ 25ºC (59º~77ºF) and avoid direct s

QUESTIONS

OTC - QUESTIONS SECTION

1-562-944-6800

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51352-12651352-126-81

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
KRAMERIA LAPPACEA ROOTP29ZH1A35ZIACT
CITRUS SINENSIS FRUIT OILWV48LBL15QIACT
SORBITOL SOLUTION8KW3E207O2IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CHAMOMILEFGL3685T2XIACT
POLIGLUSAM82LKS4QV2YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
MINTFV98Z8GITPIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM ALGINATEC269C4G2ZQIACT
STEVIOSIDE0YON5MXJ9PIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
LEVOMENTHOLBZ1R15MTK7IACT
ORTHOSILICIC ACID623B93YABHIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MYRRHJC71GJ1F3LACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2777d13f-7711-d9ad-e063-6394a90afbe308acd38f-9906-4e04-e063-6294a90ad4912024-11-21WarningsExact identifier
spl set id: 08acd38f-9906-4e04-e063-6294a90ad491

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.