FDA.reportPublic FDA data

WAIWAI GARDENIA HAND SANITIZER

Manufacturer
SRC Company Co., Ltd. | C&N COSMETICS CO.,LTD
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:15

Label at a glance#

ProductWAIWAI GARDENIA HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease. • Recommended for repeated use.

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. • Not recommended for infants

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Fragrance

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

WARNINGS

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
Do not use
• in children less than 2 months of age
• 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.

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.

Uses

INDICATIONS & USAGE SECTION

• Hand sanitizer to help reduce bacteria that potentially can cause disease.
• Recommended for repeated use.

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.
• Not recommended for infants

Other Information

OTHER SAFETY INFORMATION

• Store between 1℃-30℃ (33.8℉-86℉)
• Avoid freezing and excessive heat above 40℃ (104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78857-040-012022-01-28C16284748780-1d6a99b39-5ad4-a426-e053-dadaa90af4c2cef4dd5b-c094-41ed-bac8-054c2b8c8a5c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78857-040-01WAIWAI GARDENIA HAND SANITIZER60 mL in 1 TUBEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78857-040WAIWAI GARDENIA HAND SANITIZER (ETHYL ALCOHOL) GEL [SRC COMPANY CO., LTD.]1Legacy NDC, 1 package rows20200611_cef4dd5b-c094-41ed-bac8-054c2b8c8a5c.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
78857-04078857-040-01

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
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
Polysorbate 806OZP39ZG8HIACT

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
80fc78c8-8323-4c2d-8e7a-61289f64bf5fcef4dd5b-c094-41ed-bac8-054c2b8c8a5c2020-06-11WarningsExact identifier
spl id: 80fc78c8-8323-4c2d-8e7a-61289f64bf5f
spl set id: cef4dd5b-c094-41ed-bac8-054c2b8c8a5c

Reported adverse events (FAERS/openFDA)#

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