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NDC 63868-0608-01 OXYMETAZOLINE HYDROCHLORIDE 0.05 mg/mL Details
OXYMETAZOLINE HYDROCHLORIDE 0.05 mg/mL
OXYMETAZOLINE HYDROCHLORIDE is a NASAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION INC. The primary component is OXYMETAZOLINE HYDROCHLORIDE.
Product Information
NDC | 63868-0608 |
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Product ID | 63868-608_3421a196-7c1a-41a6-8e10-8532c58629ef |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | OXYMETAZOLINE HYDROCHLORIDE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | OXYMETAZOLINE HYDROCHLORIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | NASAL |
Active Ingredient Strength | 0.05 |
Active Ingredient Units | mg/mL |
Substance Name | OXYMETAZOLINE HYDROCHLORIDE |
Labeler Name | CHAIN DRUG MARKETING ASSOCIATION INC |
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 63868-0608-01 (63868060801)
NDC Package Code | 63868-608-01 |
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Billing NDC | 63868060801 |
Package | 30 mL in 1 BOTTLE (63868-608-01) |
Marketing Start Date | 2021-03-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL aebc7cf8-aaf7-4746-89f5-a64d0be1641e Details
Uses
Warnings
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
SPL UNCLASSIFIED SECTION
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 10-12 hours. Do not exceed 2 doses in any 24-hour period.
- children under 6 years of age: ask a doctor
- Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and turn in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hydrochloride solution |
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Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) |
Registrant - Seaway Pharma Inc. (117218785) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Seaway Pharma Inc. | 117218785 | manufacture(63868-608) |
Revised: 8/2021
Document Id: 3421a196-7c1a-41a6-8e10-8532c58629ef
Set id: aebc7cf8-aaf7-4746-89f5-a64d0be1641e
Version: 1
Effective Time: 20210801