NDC | 57896-339-05 |
Set ID | 239702af-cf93-43ee-b1af-8e53642395c1 |
Category | HUMAN OTC DRUG LABEL |
Packager | GeriCare Pharmaceutical Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART344 |
- Active ingredient
- PURPOSE
- Uses
- Warnings
- When using this product
- Keep out of the reach of children
-
Directions FOR USE IN THE EAR ONLY
- Adults and children over 12 years of age:
- Tilt head sideways and place 5 to 10 drops into ear.
- Tip of applicator should not enter ear canal.
- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
- Use twice daily for up to 4 days if needed, or as directed by a doctor.
- Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
- When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
- Children under 12 years: consult a doctor.
- Other information
- Inactive ingredients
- Principal Display Panel Bottle Label 0.5 FL OZ
- Principal Display Panel - Carton label 0.5 FL OZ
-
INGREDIENTS AND APPEARANCE
EAR WAX REMOVAL DROPS
carbamide peroxide - 6.5% solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-339 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 65 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-339-05 1 in 1 CARTON 05/27/2014 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 part344 05/27/2014 Labeler - GeriCare Pharmaceutical Corp (611196254) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(57896-339)