FDA.reportPublic FDA data

Hydrating Hand Sanitizer:Gel

Manufacturer
Natural Distributions Ltd. o/a Purple Frog Products Suite
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:37:44

Label at a glance#

ProductHydrating Hand Saintizer
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose -Antiseptic Skin cleanser 

INDICATIONS & USAGE SECTION

Use

  • Antiseptic Skin cleanser

WARNINGS SECTION

Warnings

Keep away from open flame & sources of heat.

For extenal use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children

If accidently swallowed, call a posion control center or get medical help right away.

USER SAFETY WARNINGS SECTION

Do not get into eyes

If contact occurs, rinse thoroughly with water

DOSAGE & ADMINISTRATION SECTION

  • Children,adolescents and adults 2 years and over.
  • for occasional and personal domestic use
  • supervise children when they use this product.
  • Place enough product on your plam to thoroughly cover your hands.
  • rub thoroughly into hands for at least 30 seconds
  • Allow to dry.

OTHER SAFETY INFORMATION

Other Information

  • May discolor certain fabrics or surfaces
  • do not store above 110 F ( 43 C)

INACTIVE INGREDIENT SECTION

Distilled Water, Vegetable Glycerin, Carbomer Polymer, Triethanolamine, Grapefruit essential oil blend, Aloe Barbadensis Leaf Juice, Vitamin E Extract, Denatonium Benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1111332211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80382-002-122022-01-28C16284748780-1d6a99b39-81e8-a426-e053-dadaa90af4c2Hydrating Hand Sanitizer:Gel
80382-002-602022-01-28C16284748780-1d6a99b39-81e8-a426-e053-dadaa90af4c2Hydrating Hand Sanitizer:Gel
80382-002-952022-01-28C16284748780-1d6a99b39-81e8-a426-e053-dadaa90af4c2Hydrating Hand Sanitizer:Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80382-002-12Hydrating Hand Saintizer125 mL in 1 BOTTLEGEL1254
80382-002-60Hydrating Hand Saintizer60 mL in 1 BOTTLEGEL604
80382-002-95Hydrating Hand Saintizer950 mL in 1 BOTTLEGEL9504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80382-002HYDRATING HAND SAINTIZER (ETHYL ALCOHOL) GEL [NATURAL DISTRIBUTIONS LTD. O/A PURPLE FROG PRODUCTS SUITE]4Legacy NDC, 3 package rows20210204_afc21b91-a475-3ef4-e053-2a95a90ac69f.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80382-00280382-002-95, 80382-002-12, 80382-002-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
GRAPEFRUIT OILYR377U58W9IACT
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
b4e549b9-1ce4-867d-e053-2995a90a511dafc21b91-a475-3ef4-e053-2a95a90ac69f2020-11-24WarningsExact identifier
spl id: b4e549b9-1ce4-867d-e053-2995a90a511d
spl set id: afc21b91-a475-3ef4-e053-2a95a90ac69f

Reported adverse events (FAERS/openFDA)#

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