Label: REVITALIZE ENERGIZING EYE DROPS- naphazoline hydrochloride ,propylene glycol liquid
- NDC Code(s): 82864-001-01
- Packager: Revitalize Energy Inc.
- 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 January 25, 2023
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- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
- Uses
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Warnings
For external use only
For use in the eyes only, do not drink
Ask a doctor before use if you have narrow angle glaucoma
When using this product
• Do not touch tip of container to any surface to avoid contamination
• Replace each cap after each use
• Do not use if solution changes color or becomes cloudy
• Overuse may cause more eye redness
• Pupils may become enlarged temporarily
• Remove contact lenses before use
Stop Use and ask a doctor if
• You feel eye pain
• Changes in vision occur
• Redness or irritation of the eyes lasts
• Condition worsens or lasts more than 72 hours
Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control center right away - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
REVITALIZE ENERGIZING EYE DROPS
naphazoline hydrochloride ,propylene glycol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82864-001 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.03 g in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 1 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) BORNEOL (UNII: M89NIB437X) CAFFEINE (UNII: 3G6A5W338E) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POTASSIUM ASPARTATE (UNII: OC4598NZEQ) WATER (UNII: 059QF0KO0R) TAURINE (UNII: 1EQV5MLY3D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82864-001-01 1 in 1 CARTON 02/01/2023 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 02/01/2023 Labeler - Revitalize Energy Inc. (063414745)
