Keeper medal

Manufacturer
AML Bio Co., Ltd.
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:46

Label at a glance#

ProductKeeper medal
Active ingredientMINERAL OIL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

mineral complex

OTC - PURPOSE SECTION

antiseptic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

apply proper amount to the subject area

WARNINGS SECTION

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

for external use only

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81016-0001-12022-02-02C16284748780-1d6a99b39-98cb-a426-e053-dadaa90af4c2Drug Facts
81016-0001-12022-01-28C16284748780-1d6a99b39-98cb-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81016-0001-1Keeper medal500 mL in 1 BOTTLELIQUID5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81016-0001KEEPER MEDAL (MINERAL) LIQUID [AML BIO CO., LTD.]3Legacy NDC, 1 package rows20240124_b3a40be1-41fa-24de-e053-2995a90a8a8f.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81016-000181016-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPACTIB

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
0fa7f8a3-35e9-31ba-e063-6294a90a5d68b3a40be1-41fa-24de-e053-2995a90a8a8f2024-01-23WarningsExact identifier
spl id: 0fa7f8a3-35e9-31ba-e063-6294a90a5d68
spl set id: b3a40be1-41fa-24de-e053-2995a90a8a8f

Reported adverse events (FAERS/openFDA)#

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