FDA.reportPublic FDA data

ISO-QUIN

Manufacturer
Cramer Products, Inc
Effective date
2014-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:02

Label at a glance#

ProductISO-QUIN
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Use whenever soap and water handwashing is not possible and to supplement handwashing. Recommended for repeated use.  Use for cleaning hands between treatments.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients                                                 Purpose

Alcohol (SDA 40-2) 68% by volume.......................Antiseptic

Uses

INDICATIONS & USAGE SECTION

Use whenever soap and water handwashing is not possible and to supplement handwashing. Recommended for repeated use.  Use for cleaning hands between treatments.

Warnings

WARNINGS SECTION


Flammable - keep away from fire or flame. For external use only. Do not use in the eyes.  Keep away from eyes.  In case of eye contact, flush eyes with water and consult a physician.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.  Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply a small amount onto hands and rub briskly until dry.  Do not rinse. Wash with soap after 10 - 15 applications or if hands are visibly soiled.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Ethomeen, Carbomer, Fragrance, Aloe Vera Gel, Vitamin E Acetate

OTC - QUESTIONS SECTION

Stock No. 093042   Mfd. by Cramer Products, Inc. Gardner, Kansas 66030 USA

QUESTIONS? (800) 345-2231 (M-F 8:00AM-5:00PM CST)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

OTC - PURPOSE SECTION

Purpose

Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionISO-QUIN GEL 4 ozimage descriptionISO-QUIN GEL 4 oz


Hand Disinfectant

World Leader in Sports Medicine Since 1918

Minimizes Spread of Germs, Infection

For Cleaning Hands Between Treatments

NET 4 Fl Oz (118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037039ethanol 68 % Topical GelPSN1
1037039ethanol 0.68 ML/ML Topical GelSCD1
1037039ethanol 68 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11960-0550-72020-01-31C16284748780-19d75b9cf-e315-f424-e053-dadaa90a57ce5abdc25c-5ea4-493b-8880-1362dacbb4ff
11960-0550-82020-01-31C16284748780-19d75b9cf-e315-f424-e053-dadaa90a57ce5abdc25c-5ea4-493b-8880-1362dacbb4ff
11960-0550-92020-01-31C16284748780-19d75b9cf-e315-f424-e053-dadaa90a57ce5abdc25c-5ea4-493b-8880-1362dacbb4ff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11960-0550-7ISO-QUIN118 mL in 1 BOTTLEGEL1181
11960-0550-8ISO-QUIN473 mL in 1 BOTTLE, PUMPGEL4731
11960-0550-9ISO-QUIN473 mL in 1 BOTTLEGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11960-0550ISO-QUIN (ALCOHOL) GEL [CRAMER PRODUCTS, INC]1Legacy NDC, 3 package rows20141209_5abdc25c-5ea4-493b-8880-1362dacbb4ff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV361
PEG-15 COCAMINEINACTIVE INGREDIENT8L6LB12TSJ1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11960-055011960-0550-7, 11960-0550-9, 11960-0550-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PEG-15 COCAMINE8L6LB12TSJIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36LOTION / TOPICAL29 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36CREAM / TOPICAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36FILM, EXTENDED RELEASE / TRANSDERMAL38.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36EMULSION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TRANSDERMAL30 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
8f8bc748-6344-4356-b6e2-4b6e82ce7d845abdc25c-5ea4-493b-8880-1362dacbb4ff2014-07-30WarningsExact identifier
spl id: 8f8bc748-6344-4356-b6e2-4b6e82ce7d84
spl set id: 5abdc25c-5ea4-493b-8880-1362dacbb4ff

Reported adverse events (FAERS/openFDA)#

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