FDA.reportPublic FDA data

Mineffect eye drops

Manufacturer
Kadesh Incoporation Co,Ltd
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:26:47

Label at a glance#

ProductMineffect eye drops
Active ingredientKAOLIN, CALCIUM FLUORIDE, IRON, FERROSOFERRIC PHOSPHATE, SODIUM CHLORIDE, PHOSPHORUS, SULFUR, TITANIUM, ZINC
Label structure10 sections

Indications and uses

• For the temporary relief of burning and irritation due to dryness of the eye. • For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Storage and handling

*Store at room temperature. *Tamper Evident: Do not use if neckband on bottle is broken or missing

Label contents#

Full prescribing information#

Activate Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alumina Silicata 5X HPUS
Calcarea Fluorica 6X HPUS
Ferrum Metallicum 7X HPUS
Ferrum Phosphoricum 7X HPUS
Natrum Muriaticum 4X HPUS
Phosphorus 6X HPUS
Sulphur 4X HPUS
Titanium Metallicum 7X HPUS
Zincum Metallicum 8X HPUS

The letters HPUS indicate that this ingredients is officially included in the Homeopathic pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Dry Eyes
Redness
Redness, Watery Eyes
Red, Inflamed Eyes
Itching, Burning, Tears
Eye Pain
Itching, Burning, Tears
Lubricant
Red, Itching Eyes

Uses

INDICATIONS & USAGE SECTION

• For the temporary relief of burning and irritation due to dryness of the eye.
• For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

Warning

WARNINGS SECTION

Do not Use* If solution changes color or becomes cloudy.

When using this product* To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

Stop use and ask a doctor*If you experience eye pain *If changes in vision *If continued redness or irritation of the eye *If condition worsens or persists for more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

STORAGE AND HANDLING SECTION

*Store at room temperature.
*Tamper Evident: Do not use if neckband on bottle is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alumina Silicata, Calcarea Silicata, Cerium Oxalicum, Distilled Water, Ferrum Muriaticum, Kali Silicatum, Magnesia Muriatica, Magnesia Sulphurica, Natrum Nitricum

Questions or Comments? 1-844-KADESH1

OTC - QUESTIONS SECTION

Mon-Fri 9am - 6pm (PST)
www.puriton.us
201, Eonju-ro, Gangnam-gu, Seoul
South Korea 06274

SPL UNCLASSIFIED SECTION

relieves dry eyes, redness
reduces itching burning / pain lubricating

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81488-001-152024-04-26C16284748780-11030e365-3b5a-111a-e063-dadaa90a10e2Mineffect eye drops
81488-001-152024-01-30C16284748780-11030e365-3b5a-111a-e063-dadaa90a10e2Mineffect eye drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81488-001-15Mineffect eye drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
81488-001-15Mineffect eye drops1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81488-001MINEFFECT EYE DROPS (ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM) SOLUTION/ DROPS [KADESH INCOPORATION CO,LTD]2Current NDC, Legacy NDC, 2 package rows20240427_e2259f58-3043-4af3-918d-d4403757aa1f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81488-00181488-001-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM SILICATES4255P4G5MIACT
CEROUS OXALATE NONAHYDRATE0UV74P3R0JIACT
WATER059QF0KO0RIACT
FERRIC CHLORIDE HEXAHYDRATE0I2XIN602UIACT
POTASSIUM SILICATEJ86L1GUL6KIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
SODIUM NITRATE8M4L3H2ZVZIACT
KAOLIN24H4NWX5COACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
IRONE1UOL152H7ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PHOSPHORUS27YLU75U4WACTIB
SULFUR70FD1KFU70ACTIB
TITANIUMD1JT611TNEACTIB
ZINCJ41CSQ7QDSACTIB

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
Mineffect eye dropsALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltde2259f58-3043-4af3-918d-d4403757aa1f2024-04-26WarningsExact identifier
ndc (package): 81488-001-15
ndc (product): 81488-001
ndc11 (package): 81488000115
spl id: 17047ea2-bae2-044a-e063-6294a90a4932
spl set id: e2259f58-3043-4af3-918d-d4403757aa1f

Reported adverse events (FAERS/openFDA)#

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