FDA.reportPublic FDA data

InSanitize

Manufacturer
JOKER AG | Guangzhou Berfly Cosmetic Co., Ltd
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:18

Label at a glance#

ProductInSanitize
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Water
  3. Carbomer Homopolymer
  4. Glycerin
  5. Aloe Vera Leaf
  6. Propylene Glycol
  7. Tert-butyl alcohol
  8. Denatonium benzoate
  9. Triisopropanolamine
  10. 3,5,5-TRIMETHYLHEXANAL

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 72% 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

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

Water
Carbomer Homopolymer
Glycerin
Aloe Vera Leaf
Propylene Glycol
Tert-butyl alcohol
Denatonium benzoate
Triisopropanolamine
3,5,5-TRIMETHYLHEXANAL

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN2
2277550ethanol 0.72 ML/ML Topical GelSCD2
2277550ethanol 72 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75757-301-012022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-022022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-032022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-042022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-052022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-062022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-072022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-082022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-092022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-102022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-112022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-122022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize
75757-301-132022-07-29C16284748780-1e4f33bdf-b3a2-d8a0-e053-dadaa90a6e4eInSanitize

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75757-301-01InSanitize30 mL in 1 BOTTLELIQUID302
75757-301-02InSanitize43 mL in 1 BOTTLELIQUID432
75757-301-03InSanitize60 mL in 1 BOTTLELIQUID602
75757-301-04InSanitize100 mL in 1 BOTTLELIQUID1002
75757-301-05InSanitize220 mL in 1 BOTTLELIQUID2202
75757-301-06InSanitize300 mL in 1 BOTTLELIQUID3002
75757-301-07InSanitize500 mL in 1 BOTTLELIQUID5002
75757-301-08InSanitize995 mL in 1 BOTTLELIQUID9952
75757-301-09InSanitize1890 mL in 1 BOTTLELIQUID18902
75757-301-10InSanitize2000 mL in 1 BOTTLELIQUID20002
75757-301-11InSanitize5000 mL in 1 BOTTLELIQUID50002
75757-301-12InSanitize10000 mL in 1 BOTTLELIQUID100002
75757-301-13InSanitize15000 mL in 1 BOTTLELIQUID150002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75757-301INSANITIZE (HAND SANITIZER) LIQUID [JOKER AG]2Legacy NDC, 13 package rows20210127_a677bc5f-0852-2018-e053-2995a90a8c2c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75757-30175757-301-01, 75757-301-02, 75757-301-03, 75757-301-04, 75757-301-05, 75757-301-06, 75757-301-07, 75757-301-08, 75757-301-09, 75757-301-10, 75757-301-11, 75757-301-12, 75757-301-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
3,5,5-TRIMETHYLHEXANALU62H30BXPJIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT

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
b9c7d729-6fa5-98b9-e053-2a95a90a587ea677bc5f-0852-2018-e053-2995a90a8c2c2021-01-26WarningsExact identifier
spl id: b9c7d729-6fa5-98b9-e053-2a95a90a587e
spl set id: a677bc5f-0852-2018-e053-2995a90a8c2c

Reported adverse events (FAERS/openFDA)#

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