LEADER ORIGINAL FORMULA EYE DROPS

Manufacturer: HANLIM PHARM. CO., LTD. | UNITED EXCHANGE CORP.
Effective date: 2010-03-18
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:24:10

Label at a glance#

ProductLEADER ORIGINAL FORMULA EYE DROPS

Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE

Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCL 0.05%....................Redness reliever

OTC - PURPOSE SECTION

For the relief of redness of the eyes due to minor eye irritations.

WARNINGS SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When Using this product

pupils may become enlarged temporarily

overuse may cause more eye redness

remove contact lenses before using

do not use if this solution changes color or become cloudy

do not touch tip of container to any surface to avoid contamination

replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if

you feel eye pain

changes in vision occur

redness or irritation of the eye lasts

condition worsens or lasts more than 72 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE SECTION

put 1 to 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age: ask a doctor

USER SAFETY WARNINGS SECTION

Other information

some users may experience a brief tingling sensation

store at 15 to 25C (59 to 77F)

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelEnter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	5
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	5
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	5
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11716-4708-8	2020-01-31	C162847	48780-1	9d75b9d0-a351-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11716-4708-8	LEADER ORIGINAL FORMULA EYE DROPS	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15		5
11716-4708-8	LEADER ORIGINAL FORMULA EYE DROPS	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11716-4708	LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]	5	Legacy NDC, 2 package rows	20100405_c815b41d-811f-4e4c-929a-383727074f91.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TETRAHYDROZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0YZT43HS7D	5
TETRAHYDROZOLINE	ACTIVE MOIETY	S9U025Y077	5
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	5
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	5

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

LEADER ORIGINAL FORMULA EYE DROPS
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE
BORIC ACID
SODIUM CHLORIDE
BENZALKONIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11716-4708	11716-4708-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB
BORIC ACID	R57ZHV85D4	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT

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 3 · 175 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION / AURICULAR (OTIC)	0.6 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	INJECTION, SOLUTION / INTRAVENOUS		210 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / TOPICAL	1.3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
312b0852-6077-491f-ae04-3a079d9bb885			c815b41d-811f-4e4c-929a-383727074f91	2010-03-18	Warnings	Exact identifier spl id: 312b0852-6077-491f-ae04-3a079d9bb885 spl set id: c815b41d-811f-4e4c-929a-383727074f91

Reported adverse events (FAERS/openFDA)#

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