OTC Medication Information: N-Drops NASAL DECONGESTANT

N-DROPS NASAL DECONGESTANT- oxymetazoline hydrochloride spray
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

Warnings

Ask doctor before use if person has heart disease, high blood pressure, thyroid disease, diabetes, or if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

When using this product
Do not exceed recommended dosage. Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center.

Directions

Adults and children 6 — 12 years (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: consult a doctor.

Inactive ingredients

Sorbitol, Hydroxy propyl methyl cellulose, Sodium Chloride, Benzalkonium Chloride, Edetate Disodium, Sodium hydroxide, Water for injection.

Questions?

Call toll-free 1-800-572-6632, weekdays, 7:00 AM — 5:30 PM EST.

• Won’t drip from nose or down throat

• Helps relieve congestion

Manufactured by:

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 — INDIA.

www.global-pharma.com

Packaging

N-DROPS NASAL DECONGESTANT oxymetazoline hydrochloride spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-010 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SORBITOL HYPROMELLOSE, UNSPECIFIED SODIUM CHLORIDE BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73921-010-15 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY 1 15 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (73921-010-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2021

Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture (73921-010)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED