FDA.reportPublic FDA data

Hydrating Hand Saintizer

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, PEG 10 Dimethicone, Grapefruit Essential Oil Blend, Aloe Barbadensis Leaf Juice, Denatonium Benzoate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111111

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616805ethanol 70 % Topical FoamPSN4
616805ethanol 0.7 ML/ML Topical FoamSCD4
616805ethanol 70 % Topical FoamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80382-001-302022-01-28C16284748780-1d6a99b39-81e5-a426-e053-dadaa90af4c2Hydrating Hand Sanitizer: foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80382-001-30Hydrating Hand Saintizer3780 mL in 1 BOTTLE, PUMPAEROSOL, FOAM37804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80382-001HYDRATING HAND SAINTIZER (ETHYL ALCOHOL) AEROSOL, FOAM [NATURAL DISTRIBUTIONS LTD. O/A PURPLE FROG PRODUCTS SUITE]4Legacy NDC, 1 package rows20210204_af746f68-ac55-613c-e053-2a95a90a200f.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
80382-00180382-001-30

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
GLYCERINPDC6A3C0OXIACT
DIMETHICONE PEG-10 PHOSPHATEO7Q5NJ7X88IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
b4e54d18-5580-9383-e053-2a95a90acfafaf746f68-ac55-613c-e053-2a95a90a200f2020-11-24WarningsExact identifier
spl id: b4e54d18-5580-9383-e053-2a95a90acfaf
spl set id: af746f68-ac55-613c-e053-2a95a90a200f

Reported adverse events (FAERS/openFDA)#

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