FDA.reportPublic FDA data

Dr. Rothmans Dermashield

Manufacturer
High Desert Pharmaceutics, Inc. | All Points Manufacturing, LLC
Effective date
2014-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:14

Label at a glance#

ProductDr. Rothmans Dermashield
Active ingredientAlcohol, Benzalkonium Chloride
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

  • Ethyl Alcohol - 62%
  • Benzalkonium Chloride - 0.10%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warning

  • Keep out of reach of children.

OTC - PURPOSE SECTION

Purpose

  • Antiseptic
  • Antibacterial

OTC - WHEN USING SECTION

Directions

  • Apply by spraying and gently spreading onto skin.

WARNINGS SECTION

Warning  

  • For external use only.
  • Flammable keep away from fire or flame
  • Do not use in eyes. In case of contact, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

Warning

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

INDICATIONS & USAGE SECTION

Sanitizer and moisturizer

DOSAGE & ADMINISTRATION SECTION

Apply by spraying and gently spreading onto skin

INACTIVE INGREDIENT SECTION

Blended Silicone Polyethers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Rothman's Dermashield

Image of bottle labelImage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1598027ethanol 62 % / benzalkonium chloride 0.1 % Topical SprayPSN1
1598027benzalkonium chloride 1 MG/ML / ethanol 0.62 ML/ML Topical SpraySCD1
1598027benzalkonium chloride 0.1 % / ethanol 62 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
89153-796-042020-01-31C16284748780-19d75b9d0-924a-f424-e053-dadaa90a57ceDr. Rothman's Dermashield Instant & Long Lasting Sanitizer/Moisturizer Advanced Formula Sanitizing Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
89153-796-04Dr. Rothmans Dermashield60 g in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
89153-796DR. ROTHMANS DERMASHIELD (INSTANT AND LONG LASTING SANITIZER AND MOISTURIZER) SPRAY [HIGH DESERT PHARMACEUTICS, INC.]1Legacy NDC, 1 package rows20150101_5f8310da-4c22-431f-8fcb-96231f91f594.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W71
ALCOHOLACTIVE MOIETY3K9958V90M1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1

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
89153-79689153-796-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Dimethicone92RU3N3Y1OIACT

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
161454eb-4b04-45c0-a304-1bc3e9a8c4ae5f8310da-4c22-431f-8fcb-96231f91f5942014-12-04WarningsExact identifier
spl id: 161454eb-4b04-45c0-a304-1bc3e9a8c4ae
spl set id: 5f8310da-4c22-431f-8fcb-96231f91f594

Reported adverse events (FAERS/openFDA)#

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