Paume Moisturizing Antibacterial Hand Gel

Manufacturer
Paume Inc | Prime Potions Inc.
Effective date
2024-01-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:58

Label at a glance#

ProductPaume Moisturizing Antibacterial Hand Gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 69% v/v

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.

DOSAGE & ADMINISTRATION SECTION

Put enough product in your palm to cover hands and rub together thoroughly until dry. Children under the age of 5 should be supervised by an adult when using this product

OTC - PURPOSE SECTION

Antimicrobial

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use -in children less than 2 years of age -on open skin wounds.

When using this product - keep out of eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if -irritation and redness develop.

INDICATIONS & USAGE SECTION

To help reduce bacteria on the skin

INACTIVE INGREDIENT SECTION

Purified water, Witch Hazel Extract, Safflower oleosomes in glycerin and aqua, Hydroxypropyl Methylcellulose, Cedarwood Essential Oil, Lavender Essential Oil, Rosemary Essential Oil, Lemon Essential Oil, Orange Essential Oil, Aloe Vera Powder 200X (certified organic).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287763ethanol 69 % Topical GelPSN4
2287763ethanol 0.69 ML/ML Topical GelSCD4
2287763ethanol 69 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80328-409-012025-07-29C16284748780-13b156c62-3058-fb37-e063-e6dba90a4e07ae6d4099-de48-9704-e053-2a95a90a5889
80328-409-022025-07-29C16284748780-13b156c62-3058-fb37-e063-e6dba90a4e07ae6d4099-de48-9704-e053-2a95a90a5889

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80328-409-01Paume Moisturizing Antibacterial Hand Gel90 mL in 1 BOTTLEGEL904
80328-409-02Paume Moisturizing Antibacterial Hand Gel500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80328-409PAUME MOISTURIZING ANTIBACTERIAL HAND GEL (ALCOHOL) GEL [PAUME INC]4Legacy NDC, 2 package rows20240127_ae6d4099-de48-9704-e053-2a95a90a5889.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
80328-40980328-409-01, 80328-409-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
0fdd707a-8565-c0e9-e063-6294a90a1febae6d4099-de48-9704-e053-2a95a90a58892024-01-26WarningsExact identifier
spl id: 0fdd707a-8565-c0e9-e063-6294a90a1feb
spl set id: ae6d4099-de48-9704-e053-2a95a90a5889

Reported adverse events (FAERS/openFDA)#

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