FDA.reportPublic FDA data

No-washing Hand Sanitizer

Manufacturer
Wuxi Sakura Dream Cosmetics Co.,Ltd
Effective date
2020-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:03

Key Label Information#

Active Ingredients And Purpose

Active ingredients

75% ethanol

Purpose

antimicrobial

Uses

Uses

Hand Sanitizer to help reduce bacteria on skin

Warnings

Warnings

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

Do Not Use

in children less than 2 months of age or on open skin wounds

Stop use and ask a doctor

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

Directions And Dosage

Directions

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 Label Information

Other information

Store between15-30℃(59-86°F) Avoid freezing and excessive heat above 40℃(104°F)

Inactive ingredients

Triethanolamine,Carbomer,fragrance, Water.

Package Label Principal Display Panel

Label Images#

label 1
label 1
label 2
label 2
label 3
label 3
label 4
label 4
label 5
label 5

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
79591-001-012021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-022021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-032021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-042021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-052021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-062021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-072021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-082021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-092021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-102021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-112021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-122021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-132021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-142021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-152021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-162021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-172021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-182021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-192021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer
79591-001-202021-07-23C16284748780-1c7ccaba7-272d-fd44-e053-dadaa90aa01bNo-washing Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79591-001-01No-washing Hand Sanitizer30 mL in 1 BOTTLEGEL301
79591-001-02No-washing Hand Sanitizer50 mL in 1 BOTTLEGEL501
79591-001-03No-washing Hand Sanitizer60 mL in 1 BOTTLEGEL601
79591-001-04No-washing Hand Sanitizer75 mL in 1 BOTTLEGEL751
79591-001-05No-washing Hand Sanitizer100 mL in 1 BOTTLEGEL1001
79591-001-06No-washing Hand Sanitizer120 mL in 1 BOTTLEGEL1201
79591-001-07No-washing Hand Sanitizer125 mL in 1 BOTTLEGEL1251
79591-001-08No-washing Hand Sanitizer200 mL in 1 BOTTLEGEL2001
79591-001-09No-washing Hand Sanitizer236 mL in 1 BOTTLEGEL2361
79591-001-10No-washing Hand Sanitizer240 mL in 1 BOTTLEGEL2401
79591-001-11No-washing Hand Sanitizer250 mL in 1 BOTTLEGEL2501
79591-001-12No-washing Hand Sanitizer300 mL in 1 BOTTLEGEL3001
79591-001-13No-washing Hand Sanitizer400 mL in 1 BOTTLEGEL4001
79591-001-14No-washing Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79591-001-15No-washing Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79591-001-16No-washing Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
79591-001-17No-washing Hand Sanitizer3000 mL in 1 BOTTLEGEL30001
79591-001-18No-washing Hand Sanitizer3790 mL in 1 BOTTLEGEL37901
79591-001-19No-washing Hand Sanitizer5000 mL in 1 BOTTLEGEL50001
79591-001-20No-washing Hand Sanitizer10000 mL in 1 BOTTLEGEL100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79591-001NO-WASHING HAND SANITIZER GEL [WUXI SAKURA DREAM COSMETICS CO.,LTD]1Legacy NDC, 20 package rows20200712_aa28590e-e9d3-6929-e053-2a95a90a77bb.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79591-00179591-001-01, 79591-001-02, 79591-001-03, 79591-001-04, 79591-001-05, 79591-001-06, 79591-001-07, 79591-001-08, 79591-001-09, 79591-001-10, 79591-001-11, 79591-001-12, 79591-001-13, 79591-001-14, 79591-001-15, 79591-001-16, 79591-001-17, 79591-001-18, 79591-001-19, 79591-001-20

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Complete SPL Sections#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

75% ethanol

Purpose

OTC - PURPOSE SECTION

antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

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

Do Not Use

OTC - DO NOT USE SECTION

in children less than 2 months of age or on open skin wounds

When using this product

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

OTC - STOP USE SECTION

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

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.

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 between15-30℃(59-86°F) Avoid freezing and excessive heat above 40℃(104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Triethanolamine,Carbomer,fragrance, Water.

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML