Proandre

Manufacturer
Proandre SL
Effective date
2017-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:51:40

Label at a glance#

ProductProandre
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Uses * Hand Sanitizer to help reduce bacteria that potentially may cause disease

Dosage and administration

Directions * Pump liquid into dry hands, wet thoroughly and rub into skin until dry. * Children under 6 years of age should be supervised by an adult when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Alcohol Denat 68%............ Antibacterial

Uses

INDICATIONS & USAGE SECTION

Uses

* Hand Sanitizer to help reduce bacteria that potentially may cause disease

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flame

When using this product

* Avoid contact with face, eyes and broken skin.

If eye contact occurs, flush thoroughly with water

and seek medical advice.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Irritation and redness develops

Keep out of reach of children

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

Directions

* Pump liquid into dry hands, wet thoroughly and rub

into skin until dry.

* Children under 6 years of age should be supervised by an

adult when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl betaine

Questions?

OTC - QUESTIONS SECTION

Questions?

1(305) 961 1156

Uses

OTC - PURPOSE SECTION

Hand sanitizer to help reduce bacteria on hands. Avoid

contact with broken skin

Antibacterial Hand Sanitizer Foam

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibacterial Hand Sanitizer Foam

Fragrance Free

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70028-003-112020-01-31C16284748780-19d75b9d0-5f6b-f424-e053-dadaa90a57ceAntibacterial Handsanitizer Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70028-003-11Proandre800 mL in 1 BOTTLE, DISPENSINGAEROSOL, FOAM8003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70028-003PROANDRE (ALCOHOL DENAT) AEROSOL, FOAM [PROANDRE SL]3Legacy NDC, 1 package rows20170620_1dca500a-3655-0d15-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
CARBOMER 1342INACTIVE INGREDIENT809Y72KV361
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70028-00370028-003-11

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
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36EMULSION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TRANSDERMAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36FILM, EXTENDED RELEASE / TRANSDERMAL38.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36LOTION / TOPICAL29 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36CREAM / TOPICAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
526213f2-af27-1393-e054-00144ff88e881dca500a-3655-0d15-e054-00144ff8d46c2017-06-20WarningsExact identifier
spl id: 526213f2-af27-1393-e054-00144ff88e88
spl set id: 1dca500a-3655-0d15-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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