Label: FOSTER AND THRIVE EARWAX REMOVAL DROPS- carbamide peroxide solution/ drops
- NDC Code(s): 70677-1154-1
- Packager: Mckesson Corp. Via Strategic Sourcing Services
- 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 June 8, 2023
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- 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:
- 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
Children under 12 years: consult a doctor
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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:
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INGREDIENTS AND APPEARANCE
FOSTER AND THRIVE EARWAX REMOVAL DROPS
carbamide peroxide solution/ dropsProduct Information Product Type HUMAN OTC DRUG 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 05/31/2023 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 final M014 05/31/2023 Labeler - Mckesson Corp. Via Strategic Sourcing Services (116956644)