Label: PRIVINE- naphazoline hydrochloride suspension/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 63736-663-01 - Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
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 January 31, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (per drop)
- Purpose
- Uses
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Warnings
Do not use this product in children under 12 years of age because it may cause sedation if swallowed.
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. Use only as directed. Frequent or prolonged use may cause nasal congestion to come back or get worse.
- the use of this container or dropper by more than one person may spread infection
- Directions
- Other information
- Inactive Ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 mL Drops Carton
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INGREDIENTS AND APPEARANCE
PRIVINE
naphazoline hydrochloride suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-663 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride 0.125 mL in 25 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:63736-663-01 1 in 1 BOX 1 25 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 LLC (176792315)