TOPCARE NO DRIP EXTRA MOISTURIZING- oxymetazoline hcl spray

TOPCARE No Drip Extra Moisturizing by

Drug Labeling and Warnings

TOPCARE No Drip Extra Moisturizing by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiroty allergies
• temporarily relieves sinus congestion and pressure
• Shrinks swollen membranes so you can breathe more freely

Warnings

Ask a Doctor before use if you have

• heart diease
• high blood pressure
• diabetes
• thyiod diease
• trouble urinating due to enlarged rostate gland.

When using this product 

• Do not use more than directed
• do not use for more than three 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 the reach of children

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

Directions

• Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
• Wipe nozzle clean after use.
• Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age consult a doctor.

Other Information 

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

Inactive Ingredients 

Benzalkonium Chloride Solution, Benzyl Alcohol, Edetate Disodium, Flavor, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol, Povidone, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Panel -Bottle label 

TOPCO          NDC: 36800-561-30

No Drip

Nasal Spray

Oxymetazoline HCL 0.05%Extra Moisturizing 

NasaL Decongestant 

NET WT 1 FL.OZ (30ml)

Principal Panel -Carton label

TOPCO                NDC: 36800-561-30
No Drip

Nasal Spray

Oxymetazoline HCL 0.05%Extra Moisturizing

NasaL Decongestant

NET WT 1 FL.OZ (30ml)

INGREDIENTS AND APPEARANCE

TOPCARE NO DRIP EXTRA MOISTURIZING 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-561
Route of Administration	NASAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-561-30	1 in 1 CARTON	04/30/2022
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/30/2022

Labeler - Topco Associates LLC (006935977)