FDA.reportPublic FDA data

SANICOP

Manufacturer
vinicop s.a. de c.v.
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:15:07

Label at a glance#

ProductSANICOP
Active ingredientALCOHOL
Label structure12 sections

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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 67% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use:

· in children less than 2 months of age

· on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. 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. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

· Store between 15-30ºC (59-86ºF)

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glyceryn, Water, TEA, Carbomer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

.473 L NDC: 77208-001-09

SANICOP LABEL .473 L BOTTLESANICOP LABEL .473 L BOTTLE

.236L NDC: 77208-001-10

SANICOP LABEL .236 L BOTTLESANICOP LABEL .236 L BOTTLE

1L NDC: 77208-001-05 SANICOP LABEL 1L APSANICOP LABEL 1L AP

1L NDC: 77208-001-07 SANICOP LABEL 1L BOTTLESANICOP LABEL 1L BOTTLE

1L NDC: 77208-001-06 SANICOP LABEL 1L DOSIFSANICOP LABEL 1L DOSIF

3.78L NDC: 77208-001-04 SANICOP LABEL 3.78LSANICOP LABEL 3.78L

19L NDC: 77208-001-03 SANICOP LABEL 19LSANICOP LABEL 19L

200L NDC: 77208-001-02 SANICOP LABEL 200LSANICOP LABEL 200L

1000L NDC: 77208-001-01 SANICOP LABEL 1000LSANICOP LABEL 1000L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039708ethanol 67 % Topical GelPSN2
1039708ethanol 0.67 ML/ML Topical GelSCD2
1039708ethanol 67 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77208-001-012022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-022022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-032022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-042022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-052022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-062022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-072022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-092022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b
77208-001-102022-01-28C16284748780-1d6a99b39-a733-a426-e053-dadaa90af4c2a48e5405-67ec-2e57-e053-2995a90a498b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77208-001-01SANICOP1000000 mL in 1 TANKGEL10000002
77208-001-02SANICOP200000 mL in 1 DRUMGEL2000002
77208-001-03SANICOP19000 mL in 1 PAILGEL190002
77208-001-04SANICOP3780 mL in 1 BOTTLE, PLASTICGEL37802
77208-001-05SANICOP1000 mL in 1 BOTTLE, WITH APPLICATORGEL10002
77208-001-06SANICOP1000 mL in 1 BOTTLE, PUMPGEL10002
77208-001-07SANICOP1000 mL in 1 BOTTLEGEL10002
77208-001-09SANICOP473 mL in 1 BOTTLEGEL4732
77208-001-10SANICOP236 mL in 1 BOTTLEGEL2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77208-001SANICOP (ALCOHOL) GEL [VINICOP S.A. DE C.V.]2Legacy NDC, 9 package rows20200529_a48e5405-67ec-2e57-e053-2995a90a498b.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77208-00177208-001-01, 77208-001-02, 77208-001-03, 77208-001-04, 77208-001-05, 77208-001-06, 77208-001-07, 77208-001-09, 77208-001-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
a61cdeae-db65-2db2-e053-2a95a90a266ba48e5405-67ec-2e57-e053-2995a90a498b2020-05-20WarningsExact identifier
spl id: a61cdeae-db65-2db2-e053-2a95a90a266b
spl set id: a48e5405-67ec-2e57-e053-2995a90a498b

Reported adverse events (FAERS/openFDA)#

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