FDA.reportPublic FDA data

Allergy Desensitization

Manufacturer
Peak Manufacturing and Fulfillment Inc
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:15:35

Label at a glance#

ProductAllergy Desensitization
Active ingredientONION, APIS MELLIFERA, SCHOENOCAULON OFFICINALE SEED, EUPHRASIA STRICTA
Label structure12 sections

Indications and uses

According to homeopathic principles these drops are indicated for itching, burning, watering and edema associated with ocular allergy.*

Dosage and administration

Instill 1-3 drops in the eye. Use several times per day as needed.

Storage and handling

Safe Storage Room temperature 59 o to 86 o F (15 o to 30 o C)

Label contents#

Full prescribing information#

Homeopathic Purpose

OTC - PURPOSE SECTION

Allium cepa6xRelieves itching, burning
Apis6xRelieves inflammation with burning and stinging
Sabadilla6xRelieve hay fever type symptoms
Euphrasia (Eye-bright)4xGeneral dryness, redness and irritation of the eye and lids

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allium cepa6x
Apis6x
Sabadilla6x
Euphrasia (Eye-bright)4x

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sterile water (non-preserved)
Polysorbate 80
Citrates
Sodium chloride

Uses

INDICATIONS & USAGE SECTION

According to homeopathic principles these drops are indicated for itching, burning, watering and edema associated with ocular allergy.*

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1-3 drops in the eye. Use several times per day as needed.

Warnings

WARNINGS SECTION

- For ophthalmic use.

- For Professional Use Only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Do not use

OTC - DO NOT USE SECTION

Do not use if solution becomes cloudy. If pregnant or breastfeeding, ask a health professional before use.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Stop use and ask a doctor if: You experience eye pain, changes in vision, continued redness or irritation of the eye. The condition worsens. Symptoms last longer than 72 hours.

Storage

STORAGE AND HANDLING SECTION

Safe Storage

Room temperature 59 o to 86 o F (15 o to 30 o C)

OTC - QUESTIONS SECTION

Natural Ophthalmlcs, Inc.

Dillon, CO 80435 USA

www.natoph.com

877-220-9710

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonLabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80961-125-102024-01-30C16284748780-11030e365-4ca5-111a-e063-dadaa90a10e2Allergy Desensitization

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80961-125-10Allergy Desensitization1 in 1 PACKAGELIQUID12
80961-125-10Allergy Desensitization10 mL in 1 BOTTLE, DROPPERLIQUID102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80961-125ALLERGY DESENSITIZATION (ONION, APIS MELLIFERA, SCHOENOCAULON OFFICINALE SEED, EUPHRASIA STRICTA) LIQUID [PEAK MANUFACTURING AND FULFILLMENT INC]2Legacy NDC, 2 package rows20220114_b234e0b1-538b-5750-e053-2995a90a517f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80961-12580961-125-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE451W47IQ8XIACT
ONION492225Q21HACTIB
APIS MELLIFERA7S82P3R43ZACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
EUPHRASIA STRICTAC9642I91WLACTIB

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
d57bb194-eb6c-360d-e053-2995a90af939b234e0b1-538b-5750-e053-2995a90a517f2022-01-13WarningsExact identifier
spl id: d57bb194-eb6c-360d-e053-2995a90af939
spl set id: b234e0b1-538b-5750-e053-2995a90a517f

Reported adverse events (FAERS/openFDA)#

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