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NDC 36800-0817-10 Topcare Nasal 0.05 g/100mL Details

Topcare Nasal 0.05 g/100mL

Topcare Nasal is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is OXYMETAZOLINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.

Related Packages: 36800-0817-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray

Product Information

NDC	36800-0817
Product ID	36800-817_59f39b38-4356-414e-9df0-78434402e91a
Associated GPIs	42102040102010
GCN Sequence Number	008039
GCN Sequence Number Description	oxymetazoline HCl SPRAY 0.05 % NASAL
HIC3	Q7D
HIC3 Description	NOSE PREPARATIONS, VASOCONSTRICTORS(OTC)
GCN	34062
HICL Sequence Number	003417
HICL Sequence Number Description	OXYMETAZOLINE HCL
Brand/Generic	Generic
Proprietary Name	Topcare Nasal
Proprietary Name Suffix	n/a
Non-Proprietary Name	oxymetazoline hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	0.05
Active Ingredient Units	g/100mL
Substance Name	OXYMETAZOLINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
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 36800-0817-10 (36800081710)

Pricing Information	N/A
NDC Package Code	36800-817-10
Billing NDC	36800081710
Package	1 BOTTLE in 1 CARTON (36800-817-10) / 30 mL in 1 BOTTLE
Marketing Start Date	1996-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4fac7662-6311-4698-aae9-21f5513a9900 Details

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

•: temporarily relieves nasal congestion due to:
•: common cold
•: hay fever
•: upper respiratory allergies
•: temporarily relieves sinus congestion and pressure
•: shrinks swollen nasal 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 an enlarged prostate gland

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

Stop use and ask a 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 (1-800-222-1222).

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 in any 24-hour period.
•: children under 6 years of age: ask a doctor

To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Other information

•: store at 20-25°C (68-77°F)
•: retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, monobasic sodium phosphate, polysorbate 80, propylene glycol, purified water

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO AFRIN® ALLERGY SINUS NASAL SPRAY ACTIVE INGREDIENT

Nasal Spray

NASAL DECONGESTANT OXYMETAZOLINE HCl 0.05%

ALLERGY SINUS

12 HOUR RELIEF

OUR PHARMACISTS RECOMMEND

Fast, Powerful Congestion Relief from Allergies

Reduces Swelling of Nasal Passages

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

TOPCARE NASAL

oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-817
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-817-10	1 in 1 CARTON	08/06/1996
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/06/1996

Labeler - Topco Associates LLC (006935977)

Revised: 11/2018

Document Id: 59f39b38-4356-414e-9df0-78434402e91a

Set id: 4fac7662-6311-4698-aae9-21f5513a9900

Version: 5

Effective Time: 20181128