FDA.reportPublic FDA data

Prosana Skin and Body

Manufacturer
Bodywell Natural Skin Care Inc
Effective date
2023-04-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:32:35

Label at a glance#

ProductProsana Skin and Body
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.  For use when soap and water are not available.

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic.

Uses

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to help reduce bacteria that potentially can cause disease. 
  • For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use• in children less than 2 months of age.
• on open skin or wounds.

When using this product keep out of eyes, earsand mouth. In case of contact with eyes, rinseeyes thoroughly with water.

Stop use and ask a doctor

  • if irritation occurs.
  • These may be signs of a serious condition.

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 on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information.

SPL UNCLASSIFIED SECTION

• Store between 15-30C (59-86F)
• Avoid freezing & excessive heat above 40C(104F)

Inactive Ingredients.

INACTIVE INGREDIENT SECTION

Aqua, Aloe Barbadensis (Aloe Vera) Leaf Juice,Glycerin, Isopropyl Myristate, Propylene Glycol,
Tocopheryl Acetate (Vitamin E), Aminoethyl Propanol, Carbomer, Fragrance.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

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
81441-00181441-001-01, 81441-001-02, 81441-001-03, 81441-001-04, 81441-001-05, 81441-001-06, 81441-001-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
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
2a301f1c-1db6-c27d-e063-6294a90a93f1720002ac-b074-47c9-979d-621b86d756042024-12-26WarningsExact identifier
spl set id: 720002ac-b074-47c9-979d-621b86d75604

Reported adverse events (FAERS/openFDA)#

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