FDA.reportPublic FDA data

Guangzhou SIMIKA 75% Gel

Manufacturer
Guangzhou Ouzhuang Biological Technology Co Ltd
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:01

Label at a glance#

ProductSIMIKA
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 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%

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

Do not use

OTC - DO NOT USE SECTION

  • 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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, fragrant Orchid, propylene glycol, carbomer, triethanolamine, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC:77598-133-05500 mL NDC:77598-133-05

500 mL NDC:77598-133-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77598-133-012022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-022022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-032022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-042022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-052022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-062022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-072022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-082022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-102022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-112022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77598-133-01SIMIKA30 mL in 1 BOTTLEGEL301
77598-133-02SIMIKA60 mL in 1 BOTTLEGEL601
77598-133-03SIMIKA100 mL in 1 BOTTLEGEL1001
77598-133-04SIMIKA300 mL in 1 BOTTLEGEL3001
77598-133-05SIMIKA500 mL in 1 BOTTLEGEL5001
77598-133-06SIMIKA1000 mL in 1 BOTTLEGEL10001
77598-133-07SIMIKA3800 mL in 1 BOTTLEGEL38001
77598-133-08SIMIKA5000 mL in 1 BOTTLEGEL50001
77598-133-10SIMIKA30 mL in 1 PACKETGEL301
77598-133-11SIMIKA10 mL in 1 PACKETGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77598-133SIMIKA (SANITIZING GEL) GEL [GUANGZHOU OUZHUANG BIOLOGICAL TECHNOLOGY CO LTD]1Legacy NDC, 10 package rows20200729_ab87882a-48d4-3c0d-e053-2995a90a4423.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77598-13377598-133-01, 77598-133-02, 77598-133-03, 77598-133-04, 77598-133-05, 77598-133-06, 77598-133-07, 77598-133-08, 77598-133-10, 77598-133-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
GYMNADENIA CONOPSEA WHOLETF911C619BIACT
ALCOHOL3K9958V90MACTIB

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
ab87882a-48d2-3c0d-e053-2995a90a4423ab87882a-48d4-3c0d-e053-2995a90a44232020-07-28WarningsExact identifier
spl id: ab87882a-48d2-3c0d-e053-2995a90a4423
spl set id: ab87882a-48d4-3c0d-e053-2995a90a4423

Reported adverse events (FAERS/openFDA)#

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