Rosun Hand Sanitizer Coconut

Manufacturer
Une Ame LLC
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:36

Label at a glance#

ProductRosun Hand Sanitizer Coconut
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and administration

Place enough product in your palm to throughly cover your hands. Rub hands briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • Flammable, keep away from fire or flame.
  • For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes, in case of contact; rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to throughly cover your hands.
  • Rub hands briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerol, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aminoacid, Fragrance(parfum), Water(Aqua)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81432-003-012022-07-29C16284748780-1e4f33bdf-a2e1-d8a0-e053-dadaa90a6e4eRosun Hand Sanitizer Coconut

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81432-003-01Rosun Hand Sanitizer Coconut500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81432-003ROSUN HAND SANITIZER COCONUT (ALCOHOL) GEL [UNE AME LLC]1Legacy NDC, 1 package rows20210227_bc06e435-a26a-f446-e053-2995a90a4682.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
81432-00381432-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
bc06e435-a26b-f446-e053-2995a90a4682bc06e435-a26a-f446-e053-2995a90a46822021-02-23WarningsExact identifier
spl id: bc06e435-a26b-f446-e053-2995a90a4682
spl set id: bc06e435-a26a-f446-e053-2995a90a4682

Reported adverse events (FAERS/openFDA)#

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