FDA.reportPublic FDA data

Hand Sanitizer Spray - 32016

Manufacturer
DGH Pharma, Inc.
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-07-23 05:10:06

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Spray on hands and on each side of your mask

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.10% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Spray on mask and hands to sanitize & protect against bacteria and pathogens.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact, flush eyes with water.



Stop use and ask a doctor if irritation or redness develops



Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray on hands and on each side of your mask

Inactive ingredients

INACTIVE INGREDIENT SECTION

D-Limonene, Copper Chloide, Glycerin, Magnesium Hydroxide, PEG-8, PEG-90, Phenoxyethanol, Polysorbate 20, Purified Water, Trisodium Citrate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product imageproduct image

Additional Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL Spray30 mL Spray

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860003616352GTIN-13: 0860003616352
EAN-13: 0860003616352
GTIN-12: 860003616352
UPC-A: 860003616352
GTIN storage (14 digits): 00860003616352		32016 - 1 oz Spray for Upload.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77238-241-112024-01-30C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-112024-01-30C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-212024-01-30C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-212024-01-30C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-412024-01-30C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-412024-01-30C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-112022-07-29C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-112022-07-29C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-212022-07-29C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-212022-07-29C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-112022-01-28C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-112022-01-28C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-212022-01-28C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016
77238-241-212022-01-28C16284748780-1d6a99b39-9725-a426-e053-dadaa90af4c2Hand Sanitizer Spray - 32016

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77238-24177238-241-11, 77238-241-21, 77238-241-41

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
CUPRIC CHLORIDES2QG84156OIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ANHYDROUS TRISODIUM CITRATERS7A450LGAIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32022-07-29full-release2026-05-31 23:50:17

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
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.afeccd10-c7e5-6193-e053-2995a90a9a5a2025-12-18WarningsExact identifier
ndc (package): 77238-241-11
ndc (package): 77238-241-21
ndc (package): 77238-241-41
ndc (product): 77238-241
ndc11 (package): 77238024141
ndc11 (package): 77238024111
ndc11 (package): 77238024121
spl id: 463d3ab9-e6d4-82ae-e063-6294a90ac790
spl set id: afeccd10-c7e5-6193-e053-2995a90a9a5a

Reported adverse events (FAERS/openFDA)#

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