FDA.reportPublic FDA data

Pranarom Aromaforce Alcohol antiseptic

Manufacturer
Veriditas Botanicals LLC
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:46

Label at a glance#

ProductPranarom Aromaforce Alcohol antiseptic
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Helps reduce bacteria on skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Other information

STORAGE AND HANDLING SECTION

  • Flammable. Keep away from fire, sparks, and sources of ignition.
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

OTC - WHEN USING SECTION

When using this product Keep out of eyes. In case of contact with eyes, fush thoroughly with water. Avoid contact with broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use adult
supervision. Not recommended for infants.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Rosa x damascena (Rose) Flower Water,* Glycerin,* Ricinus communis (Castor) Seed Oil,* Citrus aurantium bergamia (Bergamot) Peel Oil,* Cedrus atlantica (Cedarwood) Bark Oil,* Mentha x piperita (Peppermint) Oil,* Melaleuca alternifolia (Tea Tree) Oil.* *CERTIFIED ORGANIC

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRANARÕM

HAND SANITIZER

Moisturizing Formula

Non-Sterile Solution

AROMAFORCE(TM)

Alcohol antiseptic 70% topical solution

xx fl. oz | xx ml

PRANAROM SCIENTIFIC AROMATHERAPY

Minneapolis, MN 55427 | pranarom.us

Certified Organic

by ECOCERT ICO.

Label 1oz sizeLabel 1oz size

4 Oz Size Pranarom Hand Sanitizer4 Oz Size Pranarom Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78596-001-012023-01-30C16284748780-1f386c649-da36-0266-e053-dadaa90a7c1aHand Sanitizer
78596-001-022023-01-30C16284748780-1f386c649-da36-0266-e053-dadaa90a7c1aHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78596-001-01Pranarom Aromaforce Alcohol antiseptic30 mL in 1 BOTTLELIQUID301
78596-001-02Pranarom Aromaforce Alcohol antiseptic120 mL in 1 BOTTLELIQUID1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78596-001PRANAROM AROMAFORCE ALCOHOL ANTISEPTIC (ALCOHOL) LIQUID [VERIDITAS BOTANICALS LLC]1Legacy NDC, 2 package rows20200616_a70babce-873b-eb0f-e053-2995a90ad092.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78596-00178596-001-01, 78596-001-02

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
GLYCERINPDC6A3C0OXIACT
CASTOR OILD5340Y2I9GIACT
ALCOHOL3K9958V90MACTIB
PEPPERMINT OILAV092KU4JHIACT
CEDRUS ATLANTICA BARK OILZX5QRE4U60IACT
TEA TREE OILVIF565UC2GIACT
BERGAMOT OIL39W1PKE3JIIACT
WATER059QF0KO0RIACT
ROSA X DAMASCENA FLOWER OIL18920M3T13IACT

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
a70b9c10-1bf0-84ca-e053-2995a90a9ed2a70babce-873b-eb0f-e053-2995a90ad0922020-06-01WarningsExact identifier
spl id: a70b9c10-1bf0-84ca-e053-2995a90a9ed2
spl set id: a70babce-873b-eb0f-e053-2995a90ad092

Reported adverse events (FAERS/openFDA)#

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