Label: PRIVINE- naphazoline hydrochloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 63736-662-02 - Packager: Insight Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated July 31, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (per spray)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
When using this product
- do not exceed recommended dosage
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
- use only as directed
- Directions
- Other information
- Inactive Ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 20 mL spray label
- PRINCIPAL DISPLAY PANEL - 20 mL spray carton
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INGREDIENTS AND APPEARANCE
PRIVINE
naphazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-662 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline 0.1 mL in 20 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride (UNII: F5UM2KM3W7) sodium phosphate, dibasic (UNII: GR686LBA74) edetate disodium (UNII: 7FLD91C86K) sodium phosphate, monobasic (UNII: 3980JIH2SW) water (UNII: 059QF0KO0R) sodium chloride (UNII: 451W47IQ8X) Product Characteristics Color WHITE (clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-662-02 1 in 1 BOX 1 20 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/16/2009 Labeler - Insight Pharmaceuticals (176792315)