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NDC 63187-0701-30 Nasal 5 g/100mL Details

Nasal 5 g/100mL

Nasal is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is OXYMETAZOLINE HYDROCHLORIDE.

Product Information

NDC	63187-0701
Product ID	63187-701_e73a6f7b-fcab-44f8-941d-2f65ec95a571
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nasal
Proprietary Name Suffix	n/a
Non-Proprietary Name	Oxymetazoline Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	5
Active Ingredient Units	g/100mL
Substance Name	OXYMETAZOLINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0701-30 (63187070130)

Pricing Information	N/A
NDC Package Code	63187-701-30
Billing NDC	63187070130
Package	30 mL in 1 BOTTLE, SPRAY (63187-701-30)
Marketing Start Date	2016-05-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d9c10cc7-1a5c-43f2-87a8-5390a88d448a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

•: for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•: shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

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

When using this product

1.: do not exceed recommended dosage
2.: do not use for more than 3 days. Use only as directed.
3.: may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
4.: the use of this container by more than one person may spread infection
5.: frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask doctor if symptoms persist.

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

•: 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: consult a doctor

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

Other information

SPL UNCLASSIFIED SECTION

•: store between 20° to 25° C (68° to 77° F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

PRINCIPAL DISPLAY PANEL - 15 mL Carton

NDC 63187-701-15

Relabeled by:

Proficient Rx LP, Thousand Oaks, CA 91320

Soothing - 12 Hour

NASAL

DECONGESTANT

Spray

REGULAR

oxymetazoline

hydrochloride

0.05%

RELIEVES

CONGESTION

FAST

Compare to

active ingredient

of Afrin®

1/2 FL.OZ.

(15 mL)

INGREDIENTS AND APPEARANCE

NASAL

oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-701(NDC:0904-5711)
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY)	Oxymetazoline Hydrochloride	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Edetate Disodium (UNII: 7FLD91C86K)
Propylene Glycol (UNII: 6DC9Q167V3)
Benzyl Alcohol (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Hydrochloric Acid (UNII: QTT17582CB)
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-701-15	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/02/2016
2	NDC:63187-701-30	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/02/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/17/2009

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-701)

Revised: 11/2019

Document Id: e73a6f7b-fcab-44f8-941d-2f65ec95a571

Set id: d9c10cc7-1a5c-43f2-87a8-5390a88d448a

Version: 3

Effective Time: 20191101

Search by Drug Name or NDC

NDC 63187-0701-30 Nasal 5 g/100mL Details

Nasal 5 g/100mL

Product Information

Package

Package Images

NDC 63187-0701-30 (63187070130)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d9c10cc7-1a5c-43f2-87a8-5390a88d448a Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

SPL UNCLASSIFIED SECTION

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL - 15 mL Carton

INGREDIENTS AND APPEARANCE

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