RHINASE D GEL MOISTURIZING NASAL DECONGESTANT- oxymetazoline hcl 0.5% jelly

Rhinase D Gel Moisturizing Nasal Decongestant by

Drug Labeling and Warnings

Rhinase D Gel Moisturizing Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Profounda Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient........Purpose

Oxymetalozine 0.05%.....Nasal Decongestant

ASK DOCTOR

Stop use and ask a doctor if symptoms persist

PURPOSE

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

WHEN USING

- 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.

PREGNANCY OR BREAST FEEDING

If pregnant or brreast feeding ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a poisen control center right away

QUESTIONS

Please call 407-270-7790

DOSAGE & ADMINISTRATION

Adults and Children 6 to under 12 years of age (with adult supervision) Place a small amount in each nostril and inhale well back into the nasal passages, not more often than every 10-12 hours. Do not exceed 2 doses in any 24 hour period.

children under 6 years of age ask a doctor.

To Use: press down grooved white cap firmly and turn counter clockwise . Secure cap after use.

WARNINGS

Ask a doctor if you have - heart disease - high blood pressure - trouble urinating due to a thyroid disease - diabetes - enlarged prostrate gland

INACTIVE INGREDIENT

Inactive ingredients: Purified Water, Carbopol, Sodium Carboxymethylcellulose,
Sodium

INDICATIONS & USAGE

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

INDICATIONS & USAGE

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

RhinaseD_Sachet_3g_200422_052920-FIN.jpg

NDC: 69051-202-01

Rhinase D Gel

Oxymetazoline HCL 0.05%

Moisturing Nasal Decongestant

12 hour nasal relief for congestion caused by colds and allergies

Profounda logo

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RHINASE D GEL MOISTURIZING NASAL DECONGESTANT 
oxymetazoline hcl 0.5% jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69051-202
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 {VP}  in 100 {VP}

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)	0.7 {VP}  in 100 {VP}
WATER (UNII: 059QF0KO0R)	55.5 {VP}  in 100 {VP}
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.018 {VP}  in 100 {VP}
POTASSIUM CHLORIDE (UNII: 660YQ98I10)	0.167 {VP}  in 100 {VP}
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.218 {VP}  in 100 {VP}
POLYETHYLENE GLYCOL 10000 (UNII: H57W405143)	14.993 {VP}  in 100 {VP}
DIPROPYLENE GLYCOL (UNII: E107L85C40)	19.99 {VP}  in 100 {VP}
CARBOMER 934 (UNII: Z135WT9208)	1.809 {VP}  in 100 {VP}
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.308 {VP}  in 100 {VP}

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69051-202-01	3 in 1 TUBE	12/21/2020
1		3 {VP} in 1 TUBE; 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	12/21/2020

Labeler - Profounda Inc (078862060)

Registrant - Profounda Inc (078862060)

Establishment
Name	Address	ID/FEI	Business Operations
Profounda Inc		078862060	manufacture(69051-202)