Label: FOSTER AND THRIVE EARWAX REMOVAL KIT EAR WAX DROPS- carbamide peroxide kit
- NDC Code(s): 70677-1153-1, 70677-1154-1
- Packager: Mckesson Corp. Via Strategic Sourcing Services
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
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Warnings
For use in the ear only
Ask a doctor before use if you have
- ear drainage or discharge
- irritation or rash in the ear
- dizziness
- an injury or perforation (hole) of the ear drum
- recently had ear surgery
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Directions
FOR USE IN THE EAR ONLY
Adults and children over 12 years of age:
consult a doctor Children under 12 years:
- Tilt head sideways and places 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 wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
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Other information
- Avoid exposing bottle to excessive heat and direct sunlight
- Store bottle in the outer carton
- Do not store above 25°C (77°F)
- Keep cap on bottle when not in use
- Product foams on contact with earwax due to release of oxygen. There may be an associated cracklig sound
- Do not use if tamper-evident safety seal is broken or missing
- Inactive ingredients
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
FOSTER AND THRIVE EARWAX REMOVAL KIT EAR WAX DROPS
carbamide peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1153 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1153-1 1 in 1 KIT 05/31/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 1 of 1 FOSTER AND THRIVE EARWAX REMOVAL DROPS
carbamide peroxide solution/ dropsProduct Information Item Code (Source) NDC:70677-1154 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1154-1 1 in 1 BOX 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 05/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 05/31/2023 Labeler - Mckesson Corp. Via Strategic Sourcing Services (116956644)