Label: ENT ESSENTIALS EAR WAX REMVOER- carbamide peroxide liquid
- NDC Code(s): 68093-4503-1
- Packager: Wisconsin Pharmacal Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated November 8, 2017
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
FOR USE IN THE EAR ONLY Adults and children over 12 years of age:
tilt head sideways
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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.
Children under 12 years: consult a doctor.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ENT ESSENTIALS EAR WAX REMVOER
carbamide peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68093-4503 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 0.065 g in 1 g Inactive Ingredients Ingredient Name Strength TARTARIC ACID (UNII: W4888I119H) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68093-4503-1 1 in 1 CARTON 02/01/2017 1 22 g 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 not final part356 02/01/2017 Labeler - Wisconsin Pharmacal Company (800873986) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal Company 800873986 manufacture(68093-4503)