FDA.reportPublic FDA data

Alcohol Prep

Manufacturer
Dynarex Corporation
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 01:25:52

Label at a glance#

ProductAlcohol Prep
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Dosage and administration

• When used for first aid: Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first. • When used to prepare an injection site: A pply product to the injection site prior to injection.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

• First aid to help prevent infection in minor cuts, scrapes, and burns

• For preparation of the skin prior to an injection

Warnings

WARNINGS SECTION

For External Use only

Flammable. Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

• In the eyes or over large areas of the body

• Longer than 1 week unless directed by a doctor

• With electrocautery procedures

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition persists for more than 72 hours or gets worse.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• When used for first aid: Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

• When used to prepare an injection site: Apply product to the injection site prior to injection.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1113-1116 Box Master1113-1116 Box Master

Label 1113-50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1113-50_BX_MASTER1113-50_BX_MASTER1113-50

Label 1113UB-24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1113UB-2 BX_MASTER1113UB-2 BX_MASTER1113UB-24

Label 1113UB-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1113UB-10_BX_MASTER1113UB-10_BX_MASTER1113UB-10

Label 1113-50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1113-50 BX PHFL0101113-50 BX PHFL0101113-50 PHFL010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN22
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD22
797544isopropyl alcohol 70 % Medicated PadSY22
797544isopropyl alcohol 70 % Topical ClothSY22
797544isopropyl alcohol 70 % Topical SwabSY22

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840117333307GTIN-13: 0840117333307
EAN-13: 0840117333307
GTIN-12: 840117333307
UPC-A: 840117333307
GTIN storage (14 digits): 00840117333307		1113UB-10_BX_MASTER_R231009-3.jpg
BarcodeEAN-130840117333321GTIN-13: 0840117333321
EAN-13: 0840117333321
GTIN-12: 840117333321
UPC-A: 840117333321
GTIN storage (14 digits): 00840117333321		1113UB-2 BX_MASTER_R231009-2.jpg
BarcodeEAN-130840117333345GTIN-13: 0840117333345
EAN-13: 0840117333345
GTIN-12: 840117333345
UPC-A: 840117333345
GTIN storage (14 digits): 00840117333345		1113-50 BX PHFL010 (R250721-1).jpg, 1113-50_BX_MASTER_R231009-2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-121-11Alcohol Prep200 in 1 BOXSWAB20022
67777-121-12Alcohol Prep10 in 1 CASESWAB1022
67777-121-13Alcohol Prep0.55 mL in 1 POUCHSWAB0.5522
67777-121-14Alcohol Prep0.55 mL in 1 POUCHSWAB0.5522
67777-121-16Alcohol Prep0.7 mL in 1 POUCHSWAB0.722
67777-121-17Alcohol Prep100 in 1 BOXSWAB10022
67777-121-18Alcohol Prep10 in 1 CASESWAB1022
67777-121-19Alcohol Prep100 in 1 BOXSWAB10022
67777-121-20Alcohol Prep20 in 1 CASESWAB2022
67777-121-21Alcohol Prep24 in 1 BOXSWAB2422
67777-121-21Alcohol Prep0.55 mL in 1 POUCHSWAB0.5522
67777-121-22Alcohol Prep100 in 1 CASESWAB10022
67777-121-23Alcohol Prep0.55 mL in 1 POUCHSWAB0.5522
67777-121-23Alcohol Prep10 in 1 BOXSWAB1022
67777-121-24Alcohol Prep100 in 1 CASESWAB10022
67777-121-26Alcohol Prep40 in 1 CASESWAB4022
67777-121-27Alcohol Prep0.55 mL in 1 POUCHSWAB0.5522
67777-121-27Alcohol Prep50 in 1 BOXSWAB5022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-121-11EA - Each67777-121f0d6d8bb-6ede-4b6a-bc0b-de88d7bd582c12023-05-05
67777-121-12EA - Each67777-12122e9e160-b364-4736-b766-be4e1ab7113912023-05-05
67777-121-13EA - Each67777-12119256bf2-f8af-48f9-a20e-7f8c5ed88aba12013-09-04
67777-121-14EA - Each67777-1217ffd58d9-58b8-4b5f-bfff-7441237a189f12013-09-04
67777-121-16EA - Each67777-12199ff6187-6cfd-4ff4-8ec3-447c225e3ac712013-09-04
67777-121-17EA - Each67777-12147c3d0da-a5d9-4bf9-97cb-5728a8058c3d12023-06-06
67777-121-18EA - Each67777-121c116d4dd-7485-45f7-8b37-12cd4e2ed48f12023-06-06
67777-121-19EA - Each67777-1212cb7b840-58ea-49b6-820b-2660b97b7ec112023-06-06
67777-121-20EA - Each67777-12134ca751e-ab5c-423d-b9c2-0adcef67d67b12023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163026
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163026
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-12167777-121-14, 67777-121-19, 67777-121-20, 67777-121-16, 67777-121-17, 67777-121-18, 67777-121-13, 67777-121-11, 67777-121-12, 67777-121-27, 67777-121-26, 67777-121-21, 67777-121-22, 67777-121-23, 67777-121-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
ndc (package): 67777-121-18
ndc (package): 67777-121-12
ndc (package): 67777-121-26
ndc (package): 67777-121-11
ndc (package): 67777-121-22
ndc (package): 67777-121-24
ndc (package): 67777-121-19
ndc (package): 67777-121-27
ndc (package): 67777-121-13
ndc (package): 67777-121-23
ndc (package): 67777-121-16
ndc (package): 67777-121-21
ndc (package): 67777-121-17
ndc (package): 67777-121-20
ndc (package): 67777-121-14
ndc (product): 67777-121
ndc11 (package): 67777012127
ndc11 (package): 67777012117
ndc11 (package): 67777012113
ndc11 (package): 67777012120
ndc11 (package): 67777012126
ndc11 (package): 67777012116
ndc11 (package): 67777012112
ndc11 (package): 67777012121
ndc11 (package): 67777012114
ndc11 (package): 67777012123
ndc11 (package): 67777012118
ndc11 (package): 67777012124
ndc11 (package): 67777012122
ndc11 (package): 67777012119
ndc11 (package): 67777012111
spl id: 461840ed-4af3-c2fb-e063-6294a90ab572
spl set id: 39b20f1b-8d2f-4fa0-8cb9-10cad408e064

Reported adverse events (FAERS/openFDA)#

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