FDA.reportPublic FDA data

Pharma Cleanse HAND SANITIZER

Manufacturer
Ballistic LLC | GUANGZHOU XUELEI COSMETIC CO.,LTD.
Effective date
2021-11-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:50

Label at a glance#

ProductPharma Cleanse HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

Dosage and administration

DISPENSE ONE PUMP OF SANITIZER ON TO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

Storage and handling

STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 75%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES:

INDICATIONS & USAGE SECTION

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN. STOP USE AND SEEK MEDICAL ADVICE IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

DISPENSE ONE PUMP OF SANITIZER ON TO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

OTHER INFO:

STORAGE AND HANDLING SECTION

STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

WATER (AQUA), CARBOMER, TRIETHANOLAMINE.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40ml, NDC: 78528-001-01

40ml label40ml label

60ml, NDC: 78528-001-02

60ml label60ml label

500ml, NDC: 78528-001-03

500ml label500ml label

1000ml, NDC: 78528-001-04

1000ml label1000ml label

2000ml, NDC: 78528-001-05

2000ml label2000ml label

3785ml, NDC: 78528-001-06

3785ml label3785ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN3
1305100ethanol 0.75 ML/ML Topical GelSCD3
1305100ethanol 75 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78528-001-012023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-022023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-032023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-042023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-052023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-062023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78528-001-01Pharma Cleanse HAND SANITIZER40 mL in 1 BOTTLEGEL403
78528-001-02Pharma Cleanse HAND SANITIZER60 mL in 1 BOTTLEGEL603
78528-001-03Pharma Cleanse HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5003
78528-001-04Pharma Cleanse HAND SANITIZER1000 mL in 1 BOTTLE, PUMPGEL10003
78528-001-05Pharma Cleanse HAND SANITIZER2000 mL in 1 BOTTLEGEL20003
78528-001-06Pharma Cleanse HAND SANITIZER3785 mL in 1 BOTTLEGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78528-001PHARMA CLEANSE HAND SANITIZER (HAND SANITIZER) GEL [BALLISTIC LLC]3Legacy NDC, 6 package rows20211110_a7101d55-615a-5cd1-e053-2a95a90a9095.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
78528-00178528-001-01, 78528-001-02, 78528-001-03, 78528-001-04, 78528-001-05, 78528-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
TROLAMINE9O3K93S3TKIACT
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
d0532f63-1c75-6560-e053-2a95a90a5e16a7101d55-615a-5cd1-e053-2a95a90a90952021-11-08WarningsExact identifier
spl id: d0532f63-1c75-6560-e053-2a95a90a5e16
spl set id: a7101d55-615a-5cd1-e053-2a95a90a9095

Reported adverse events (FAERS/openFDA)#

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