Sanikit

Manufacturer
Renopac, S.A. de C.V.
Effective date
2023-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:12

Label at a glance#

ProductSanikit
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Health care personal hand rub to help reduce bacteria that potentially can cause disease

Dosage and administration

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

Storage and handling

Store between 15-30ºC (59-86ºF) Avoid freezing and excessive heat above 40ºC (104ºF)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT - OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% (w/w)

PURPOSE - OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Antiseptic

USES - INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

Health care personal hand rub to help reduce bacteria that potentially can cause disease

WARNINGS - WARNINGS SECTIONS

WARNINGS SECTION

For external use only.

Flammable.

Kepp away from heat or flame.

WHEN USING THIS PRODUCT - WHEN USING SECTION

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth.

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

STOP USE AND ASK A DOCTOR - STOP USE SECTION

OTC - STOP USE SECTION

If irritation or rash occur. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS - DOSAGE AND ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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

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

OTHER INFORMATION - STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

Store between 15-30ºC (59-86ºF)

Avoid freezing and excessive heat above 40ºC (104ºF)

INACTIVE INGREDIENTS - INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Purified water, carbomer, glycerin, triethanolamine.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIKIT LABELSANIKIT LABELSANIKIT 5g NDC - 79067-004-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79067-004-012024-07-30C16284748780-11030e365-3103-111a-e063-dadaa90a10e2003e98b4-c97c-4464-e063-6294a90adc35
79067-004-012024-01-30C16284748780-11030e365-3103-111a-e063-dadaa90a10e2003e98b4-c97c-4464-e063-6294a90adc35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79067-004-01Sanikit5 mL in 1 POUCHGEL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79067-004SANIKIT (HAND SANITIZER GEL) GEL [RENOPAC, S.A. DE C.V.]11 package rows20230920_003e98b4-c97c-4464-e063-6294a90adc35.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79067-00479067-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
003e98b4-c97d-4464-e063-6294a90adc35003e98b4-c97c-4464-e063-6294a90adc352023-07-12WarningsExact identifier
spl id: 003e98b4-c97d-4464-e063-6294a90adc35
spl set id: 003e98b4-c97c-4464-e063-6294a90adc35

Reported adverse events (FAERS/openFDA)#

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