FDA.reportPublic FDA data

DOCTOR SAFE

Manufacturer
ONE DIAMOND ELECTRONICS, INC.
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:23

Label at a glance#

ProductDOCTOR SAFE
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

 1) Place enough product on hands to cover all surfaces. Rub hands together until dry;  2) Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use:

1) in children less than 2 months of age;

2) on open skin wounds.

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

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

These may be signs of a serious condition. 

If swallowed, get medical help, or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Directions

DOSAGE & ADMINISTRATION SECTION

 1) Place enough product on hands to cover all surfaces. Rub hands together until dry;

 2) Supervise children under 6 years of age when using this product to avoid swallowing.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Center right away

Other Information

SPL UNCLASSIFIED SECTION

1) Store between 15-30C (59-86F);

2)Avoid freezing and excessive heat above 40C (104F

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen peroxide, Purified water USP.

1.5mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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6Packs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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12Packs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

50packs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

59mL Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

236mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78542-001-012022-01-28C16284748780-1d6a99b39-f59f-a426-e053-dadaa90af4c2DOCTOR SAFE
78542-001-022022-01-28C16284748780-1d6a99b39-f59f-a426-e053-dadaa90af4c2DOCTOR SAFE
78542-001-032022-01-28C16284748780-1d6a99b39-f59f-a426-e053-dadaa90af4c2DOCTOR SAFE
78542-001-042022-01-28C16284748780-1d6a99b39-f59f-a426-e053-dadaa90af4c2DOCTOR SAFE
78542-001-052022-01-28C16284748780-1d6a99b39-f59f-a426-e053-dadaa90af4c2DOCTOR SAFE
78542-001-062022-01-28C16284748780-1d6a99b39-f59f-a426-e053-dadaa90af4c2DOCTOR SAFE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78542-001-01DOCTOR SAFE1.5 mL in 1 POUCHGEL1.51
78542-001-02DOCTOR SAFE6 in 1 BOXGEL61
78542-001-02DOCTOR SAFE59 mL in 1 PACKAGEGEL591
78542-001-03DOCTOR SAFE12 in 1 BOXGEL121
78542-001-03DOCTOR SAFE59 mL in 1 PACKAGEGEL591
78542-001-04DOCTOR SAFE1.5 mL in 1 POUCHGEL1.51
78542-001-04DOCTOR SAFE50 in 1 BOXGEL501
78542-001-05DOCTOR SAFE59 mL in 1 BOTTLEGEL591
78542-001-06DOCTOR SAFE236 mL in 1 BOTTLEGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78542-001DOCTOR SAFE (ALCOHOL) GEL [ONE DIAMOND ELECTRONICS, INC.]1Legacy NDC, 9 package rows20200613_8541fbc2-0b3f-4ee2-a6e7-53fa9c950af5.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78542-00178542-001-01, 78542-001-02, 78542-001-03, 78542-001-04, 78542-001-05, 78542-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
2faaf829-762e-476d-b6b4-af63d0a8bef78541fbc2-0b3f-4ee2-a6e7-53fa9c950af52020-05-29WarningsExact identifier
spl id: 2faaf829-762e-476d-b6b4-af63d0a8bef7
spl set id: 8541fbc2-0b3f-4ee2-a6e7-53fa9c950af5

Reported adverse events (FAERS/openFDA)#

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