EAR CARE- benzalkonium chloride liquid 
EMS Contract Packaging

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.

----------

EMS (as CMO) - Ear Care (59228-102) - DELIST

CONTAINS

BENZALKONIUM CHLORIDE U.S.P. (1:1000)

FOR EXTERNAL USE ONLY

PURPOSE

ANTISEPTIC

THIS ANTISEPTIC IS MADE FOR THE CARE AND CLEANING OF PIERCED EARS.

CAUTION

USE SPARINGLY; EXCESSIVE USE MAY DELAY HEALING. SHOULD SWELLING OR INFECTION OCCUR, CONTACT A PHYSICIAN IMMEDIATELY.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

  1. WHEN EARS ARE NEWLY PIERCED, USE A COTTON SWAB TO CLEAN EARS TWICE DAILY.
  2. AFTER EACH APPLICATION OF EAR CARE TWIST EACH EARRING ONE COMPLETE TURN.
  3. AFTER INITIAL HEALING OF 4 WEEKS, CONTINUE TO USE EAR CARE REGULARLY TO CLEAN YOUR EARS AND EARRINGS.

ACTIVE INGREDIENTS: WATER

EMS - Artwork for EarCare Bottle1

EAR CARE 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59228-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59228-102-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/201411/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/30/201411/01/2015
Labeler - EMS Contract Packaging (048602791)

Revised: 4/2022
Document Id: dd46285d-69ba-9e77-e053-2995a90a9f71
Set id: 9461e5c3-9469-46b3-ac08-cae4f11588d5
Version: 7
Effective Time: 20220422
 
EMS Contract Packaging