FDA.reportPublic FDA data

We Care 12 Hour NASAL SPRAY DECONGESTANT

Manufacturer
We Care Distributor Inc. | PURINE PHARMA LLC
Effective date
2016-08-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:46:52

Label at a glance#

ProductNasal
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporary relieves nasal congestion due to: common cold hay fever upper respiratory allergies sinusitis shrinks swollen nasal membranes so you can breathe more freely

Dosage and administration

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours do not exceed 2 doses within any 24-hour period children under 6 years of age:  ask a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

Storage and handling

store between 20° to 25° C (68° to 77° F) retain carton for future reference on full labeling.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline Hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporary relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland

OTC - WHEN USING SECTION

When using this product: do not use more than directed

  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

OTC - STOP USE SECTION

Stop use and ask doctor if symptoms persist.

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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
  • do not exceed 2 doses within any 24-hour period
  • children under 6 years of age: ask a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

STORAGE AND HANDLING SECTION

  • store between 20° to 25° C (68° to 77° F)
  • retain carton for future reference on full labeling.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

PRINCIPAL DISPLAY PANEL - 15 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WE CARE

12 Hour NASAL SPRAY
DECONGESTANT

oxymetazoline hydrochloride 0.05%

Compare to active ingredient of Afrin

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-038-012020-01-31C16284748780-19d75b9d1-1d0a-f424-e053-dadaa90a57ceWe Care 12 Hour NASAL SPRAY DECONGESTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-038-01Nasal15 mL in 1 BOTTLE, SPRAYSPRAY152
70005-038-01Nasal1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-038NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WE CARE DISTRIBUTOR INC.]2Legacy NDC, 2 package rows20160823_8e33d7b8-2966-40da-8cee-789ef51cf317.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-03870005-038-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE SODIUMMP1J8420LUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
POVIDONEFZ989GH94EIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT

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
f19d2b1b-74ac-43b3-9a83-56dba094c7d38e33d7b8-2966-40da-8cee-789ef51cf3172016-08-23WarningsExact identifier
spl id: f19d2b1b-74ac-43b3-9a83-56dba094c7d3
spl set id: 8e33d7b8-2966-40da-8cee-789ef51cf317

Reported adverse events (FAERS/openFDA)#

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