FDA.reportPublic FDA data

Sanitizer Hand and Skin Care

Manufacturer
Immunetec Proof Ltd. | Immunetec Proof Kft. | Kedo Eurocosmetics Kft.
Effective date
2021-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:06

Label at a glance#

ProductSanitizer Hand and Skin Care
Active ingredientSILVER CHLORIDE
Label structure8 sections

Indications and uses

To help reduce the number of disease-causing bacteria, virus, and fungi until the next hand wash. For use when soap and water are not available.

Dosage and administration

• Apply after cleansing and drying the skin surface on hand or elsewhere. • Apply a generous amount and spread evenly to cover all surfaces. • Can be applied regularly.

Storage and handling

• Store between 15-30 C (59-86 F) • Avoid freezing and excessive heat above 40 C (104 F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Silver Chloride 0.3% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To help reduce the number of disease-causing bacteria, virus, and fungi until the next hand wash.

For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

OTC - WHEN USING SECTION

When using this product:

  • keep out of eyes, ears, and mouth.
  • Do not ingest.
  • In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply after cleansing and drying the skin surface on hand or elsewhere.

• Apply a generous amount and spread evenly to cover all surfaces.

• Can be applied regularly.

Other information or comments

STORAGE AND HANDLING SECTION

• Store between 15-30 C (59-86 F)
• Avoid freezing and excessive heat above 40 C (104 F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Stearic acid, Glycerin, Sodium bentonite, Phenoxyethanol, Acrylate copolymer, Triethanolamine, Caprylyl glycol, Titanium dioxide

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sanitizer Hand and Skin Care (50 mL), NDC: 81541-001-01

Outer Package (Box)

Sanitizer Hand and Skin CareSanitizer Hand and Skin Care

Inner Package (Tube)

Sanitizer Hand and Skin Care_TubeSanitizer Hand and Skin Care_Tube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81541-001-012022-07-29C16284748780-1e4f33bdf-af08-d8a0-e053-dadaa90a6e4eImmunetec Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81541-001-01Sanitizer Hand and Skin Care1 in 1 BOXCREAM13
81541-001-01Sanitizer Hand and Skin Care50 g in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81541-001SANITIZER HAND AND SKIN CARE (SILVER CHLORIDE) CREAM [IMMUNETEC PROOF LTD.]3Legacy NDC, 2 package rows20210213_ba73db2e-3ec8-fe92-e053-2995a90a463a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81541-00181541-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMERE5024Y9FFQIACT
TROLAMINE9O3K93S3TKIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENTONITEK1BPI94O04IACT
SILVER CHLORIDEMWB0804EO7ACTIM
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
bb2a3f0c-1bd8-7d7c-e053-2995a90aeee0ba73db2e-3ec8-fe92-e053-2995a90a463a2021-02-12WarningsExact identifier
spl id: bb2a3f0c-1bd8-7d7c-e053-2995a90aeee0
spl set id: ba73db2e-3ec8-fe92-e053-2995a90a463a