FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Prime Enterprises
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:04:20

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision.

Storage and handling

Do not store above 104 F May discolor some fabrics, wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For Hand Washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes, if product gets into eyes, rinse eyes with water to remove. Do not inhale or ingest.

Stop use and ask a doctor if irritation or rash develops and lasts.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 104 F
  • May discolor some fabrics, wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Citric Acid, Decyl Gucoside, Ethylhexylglycerin, Phenoxyethanol, Tetrasodium Glutamate Diacetate, Allantoin, water

OTC - QUESTIONS SECTION

Email us at info@freshtips.com

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label236 mL NDC: 58443-0338-4

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-033858443-0338-4

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
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
dbe9c520-d5de-6beb-e053-2a95a90a274fa7adbae0-c499-5a96-e053-2995a90a9e0d2022-04-05WarningsExact identifier
spl id: dbe9c520-d5de-6beb-e053-2a95a90a274f
spl set id: a7adbae0-c499-5a96-e053-2995a90a9e0d

Reported adverse events (FAERS/openFDA)#

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