FDA.reportPublic FDA data

PUROMA Hand Sanitizer Fragrance Free

Manufacturer
ZENITH MICRO CONTROL
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:22

Label at a glance#

ProductPUROMA Hand Sanitizer Fragrance Free
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Spray enough product on hands to cover all surfaces. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using Puroma hand sanitizer

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% V/V

Purpose

OTC - PURPOSE SECTION

Antimicrobial.

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin that potentially can cause disease.

For use when soap and water are not available.

Warnings

WARNINGS SECTION

• Flammable. Keep away from fire or flame.
• When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
• Stop use and ask a doctor if irritation or rash appears and lasts.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Spray enough product on hands to cover all surfaces. Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using Puroma hand sanitizer

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate

Other information

SPL UNCLASSIFIED SECTION

• Store below 110°F (43°C).
• May discolor certain fabrics or surfaces.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-010-012025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-022025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-042025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-052025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-062025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-072025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-092025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-102025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-132025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-142025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-172025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-182025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-192025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-202025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-212025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-222025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-262025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-272025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-302025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-332025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-352025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-362025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-372025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-382025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-412025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-422025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-442025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-502025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-512025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-522025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-532025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-542025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-582025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-592025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-602025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-622025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-632025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-652025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-662025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-672025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-692025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-732025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-752025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-762025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-782025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-802025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-812025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-822025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-842025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-872025-01-30C16284748780-12cef2736-5a26-d83d-e063-dadaa90ab31f65a0ca4e-389e-4c66-a160-2ef0122ef481

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-010-01PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-01PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-02PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-02PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-03PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-03PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-04PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-04PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-05PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-05PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-06PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-06PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-07PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-07PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-08PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-08PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-09PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-09PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-10PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-10PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-11PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-11PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-12PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-12PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-13PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-13PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-14PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-14PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-15PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-15PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-16PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-16PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-17PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-17PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-18PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-18PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-19PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-19PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-20PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-20PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-21PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-21PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-22PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-22PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-23PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-23PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-24PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-24PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-25PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-25PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-26PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-26PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-27PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-27PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-28PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-28PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-29PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-29PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-30PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-30PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-31PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-31PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-32PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-32PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-33PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-010-33PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-34PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-34PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-35PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-35PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-36PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-36PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-37PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-37PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-38PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-38PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-39PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-39PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-40PUROMA Hand Sanitizer Fragrance Free500 mL in 1 BOTTLELIQUID5003
80948-010-40PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-010-41PUROMA Hand Sanitizer Fragrance Free500 mL in 1 BOTTLELIQUID5003
80948-010-41PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-42PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-42PUROMA Hand Sanitizer Fragrance Free500 mL in 1 BOTTLELIQUID5003
80948-010-43PUROMA Hand Sanitizer Fragrance Free5000 mL in 1 CANLIQUID50003
80948-010-44PUROMA Hand Sanitizer Fragrance Free50000 mL in 1 CANLIQUID500003
80948-010-45PUROMA Hand Sanitizer Fragrance Free200000 mL in 1 DRUMLIQUID2000003
80948-010-46PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-46PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-47PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-47PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-48PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-48PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-49PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-49PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-50PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-50PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-51PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-51PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-52PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-52PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-53PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-53PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-54PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-54PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-55PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-55PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-56PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-56PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-57PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-57PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-58PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-58PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-59PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-59PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-60PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-60PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-61PUROMA Hand Sanitizer Fragrance Free100 mL in 1 BOTTLELIQUID1003
80948-010-61PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-62PUROMA Hand Sanitizer Fragrance Free100 mL in 1 BOTTLELIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-010PUROMA HAND SANITIZER FRAGRANCE FREE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 168 package rows20231215_65a0ca4e-389e-4c66-a160-2ef0122ef481.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80948-01080948-010-01, 80948-010-02, 80948-010-03, 80948-010-04, 80948-010-05, 80948-010-06, 80948-010-07, 80948-010-08, 80948-010-09, 80948-010-10, 80948-010-11, 80948-010-12, 80948-010-13, 80948-010-14, 80948-010-15, 80948-010-16, 80948-010-17, 80948-010-18, 80948-010-19, 80948-010-20, 80948-010-21, 80948-010-22, 80948-010-23, 80948-010-24, 80948-010-25, 80948-010-26, 80948-010-27, 80948-010-28, 80948-010-29, 80948-010-30, 80948-010-31, 80948-010-32, 80948-010-33, 80948-010-34, 80948-010-35, 80948-010-36, 80948-010-37, 80948-010-38, 80948-010-39, 80948-010-40, 80948-010-41, 80948-010-42, 80948-010-43, 80948-010-44, 80948-010-45, 80948-010-46, 80948-010-47, 80948-010-48, 80948-010-49, 80948-010-50, 80948-010-51, 80948-010-52, 80948-010-53, 80948-010-54, 80948-010-55, 80948-010-56, 80948-010-57, 80948-010-58, 80948-010-59, 80948-010-60, 80948-010-61, 80948-010-62, 80948-010-63, 80948-010-64, 80948-010-65, 80948-010-66, 80948-010-67, 80948-010-68, 80948-010-69, 80948-010-70, 80948-010-71, 80948-010-72, 80948-010-73, 80948-010-74, 80948-010-75, 80948-010-76, 80948-010-77, 80948-010-78, 80948-010-79, 80948-010-80, 80948-010-81, 80948-010-82, 80948-010-83, 80948-010-84, 80948-010-85, 80948-010-86, 80948-010-87

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERYL OLEATE4PC054V79PIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
ALCOHOL3K9958V90MACTIB

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
0c779961-2494-1090-e063-6294a90a0ff765a0ca4e-389e-4c66-a160-2ef0122ef4812023-12-14WarningsExact identifier
spl id: 0c779961-2494-1090-e063-6294a90a0ff7
spl set id: 65a0ca4e-389e-4c66-a160-2ef0122ef481

Reported adverse events (FAERS/openFDA)#

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