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NDC 36800-0561-30 TOPCARE No Drip Extra Moisturizing 0.05 g/100mL Details
TOPCARE No Drip Extra Moisturizing 0.05 g/100mL
TOPCARE No Drip Extra Moisturizing is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. 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: 36800-0561-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 36800-0561 |
|---|---|
| Product ID | 36800-561_656aa667-2b3c-486c-b722-8c71441a1ae3 |
| 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 | TOPCARE No Drip Extra Moisturizing |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Oxymetazoline HCL |
| 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 | Topco Associates LLC |
| 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 | 2023-12-31 |
Package
Package Images
NDC 36800-0561-30 (36800056130)
| NDC Package Code | 36800-561-30 |
|---|---|
| Billing NDC | 36800056130 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (36800-561-30) / 30 mL in 1 BOTTLE, PUMP |
| Marketing Start Date | 2022-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7a7fdaac-fafd-4cc1-8e6a-e843735ca6e7 Details
Uses
Ask a Doctor before use if you have
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.
Keep out of the reach of children
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
Inactive Ingredients
Principal Panel -Bottle label
Principal Panel -Carton label
INGREDIENTS AND APPEARANCE
| TOPCARE NO DRIP EXTRA MOISTURIZING
oxymetazoline hcl spray |
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| Labeler - Topco Associates LLC (006935977) |
Revised: 4/2022
Document Id: 656aa667-2b3c-486c-b722-8c71441a1ae3
Set id: 7a7fdaac-fafd-4cc1-8e6a-e843735ca6e7
Version: 2
Effective Time: 20220407