ULine F640F

Manufacturer: Uline | Kutol Products Company
Effective date: 2026-10-20
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: daily-update
Hydrated at: 2026-10-23 01:01:43

Label at a glance#

ProductAntibacterial

Active ingredientBENZALKONIUM CHLORIDE

Label structure8 sections

Indications and uses

For handwashing to decrease bacteria on skin.

Dosage and administration

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antibacterial Handwashing

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin.

Warnings

WARNINGS SECTION

For external use only.
Avoid contact with eyes. If contact occurs, flush with water.
Stop use and ask a doctor if, in rare instances, redness or irritation develop and persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds.
Add water, lather, rinse.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Lauramine Oxide, PEG-7 Glyceryl Cocoate, Glycerin, Laurtrimonium Chloride, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyquaternium-7, Fragrance, Wheat Amino Acids, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Methychloroisothiazolinone, Red 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - S19493Principal Display Panel - S18234Principal Display Panel - S18231

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69790-640-07	2022-01-31	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-07	2022-01-31	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-24	2022-01-31	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-24	2022-01-31	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-31	2022-01-31	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-31	2022-01-31	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-07	2022-01-28	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-07	2022-01-28	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-24	2022-01-28	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-24	2022-01-28	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-31	2022-01-28	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F
69790-640-31	2022-01-28	C162847	48780-1	d6a99b39-c973-a426-e053-dadaa90af4c2	ULine F640F

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Antibacterial
Benzalkonium Chloride
BENZALKONIUM
WATER
LAURAMINE OXIDE
PEG-7 GLYCERYL COCOATE
GLYCERIN
LAURTRIMONIUM CHLORIDE
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
POLYQUATERNIUM-7
CITRUS RETICULATA FRUIT OIL
WHEAT AMINO ACIDS
ALOE BARBADENSIS LEAF JUICE
ALPHA-TOCOPHEROL ACETATE
METHYLISOTHIAZOLINONE
METHYLCHLOROISOTHIAZOLINONE
RED 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69790-640	69790-640-07, 69790-640-24, 69790-640-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
WATER	059QF0KO0R	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
PEG-7 GLYCERYL COCOATE	VNX7251543	IACT
GLYCERIN	PDC6A3C0OX	IACT
LAURTRIMONIUM CHLORIDE	A81MSI0FIC	IACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE	H2KVQ74JM4	IACT
POLYQUATERNIUM-7	0L414VCS5Y	IACT
CITRUS RETICULATA FRUIT OIL	25P9H3QU5E	IACT
WHEAT AMINO ACIDS	0370GZL32F	IACT
ALOE BARBADENSIS LEAF JUICE	RUE8E6T4NB	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
RED 33	9DBA0SBB0L	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2023-08-24	legacy-cache	2026-08-01 21:26:54

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N000004-004	PAREDRINE	HYDROXYAMPHETAMINE HYDROBROMIDE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-11-14 07:37:17	2026-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3bdfa0b2c4d7…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
03a8a3c7-0f60-277e-e063-6294a90ac88d			92730c66-127f-c90b-e053-2995a90a4823	2023-08-24	Warnings	Exact identifier spl set id: 92730c66-127f-c90b-e053-2995a90a4823

Reported adverse events (FAERS/openFDA)#

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