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NDC 70000-0001-01 leader nasal 0.05 g/100mL Details
leader nasal 0.05 g/100mL
leader nasal is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0001-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 70000-0001 |
|---|---|
| Product ID | 70000-0001_f320e8fc-c536-403d-ac55-ea0ce6c767ab |
| 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 | leader 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 | Cardinal Health 110, LLC. dba Leader |
| 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 70000-0001-01 (70000000101)
| NDC Package Code | 70000-0001-1 |
|---|---|
| Billing NDC | 70000000101 |
| Package | 1 BOTTLE in 1 CARTON (70000-0001-1) / 30 mL in 1 BOTTLE |
| Marketing Start Date | 2020-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.07251 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | NASAL SPRAY 0.05% |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 3e77b550-edd6-4027-a63f-5a05d46bb69a Details
Uses
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
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- 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
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- use of this container by more than one person may spread infection
Directions
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- 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: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered 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 nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.
Other information
Inactive ingredients
Principal Display Panel
Maximum Strength | No Drip
Nasal Spray
Oxymetazoline HCl, 0.05%
Nasal Decongestant
Original
Won’t Drip from Nose or Down Throat
Pump Mist
Fast, Powerful Congestion Relief
Colds, Allergies
12-Hour Relief
COMPARE TO AFRIN® NO DRIP active ingredient
100% Money Back Guarantee
1 FL OZ (30 mL)
DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
INGREDIENTS AND APPEARANCE
| LEADER NASAL
oxymetazoline hydrochloride spray |
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| Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |