INVERNESS EAR CARE ANTISEPTIC- benzalkonium chloride solution 
Inverness Corp

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.

----------

Inverness EAR CARE ANTISEPTIC

Inverness EAR CARE ANTISEPTIC

Active Ingredient

Benzalkonium Chloride 0.12% w/w

Purpose

Ear Care Antiseptic

Use for care of your pierced ears

Warnings

  • For external use only.
  • Do not ingest.
  • If swallowed, get medical help or contact Poison Control Center immediately.
  • In case of contact with eyes, flush with water.

SEEK MEDICAL ATTENTION IF IRRITATION PERSISTS

  • Keep out of reach of children.
  • Pain, redness, or swelling is not a normal result of ear piercing.
  • Call your doctor if any type of discomfort occurs.
  • Remove earrings immediately.

Directions

For optimal results, follow these steps every day:

  • Clean hands thoroughly with antibacterial soap before touching ears and earrings.
  • Using cotton swab, cleanse front and back of ears 3 times a day with Ear Care Antiseptic. Gently rotate the earrings 2 or 3 times a day. DO NOT remove earrings.
  • Keep hair, hair spray, shampoo, soap, cosmetics, perfume, etc. away from newly pierced ears. After shampooing, exercising, swimming, hot tubs, or use of any of the above products, rinse your ears in clear water and reapply Ear Care Antiseptic, (step 2), to your ears.

Other Information

EAR LOBE PIERCING

  • Leave earrings in your ears for 6 weeks.
  • After 6 weeks the earrings may be removed; however, some type of post earring must be worn at all time during the first 6 months.

EAR CARTILAGE PIERCING

  • Leave earrings in your ears for 12 weeks.
  • After 12 weeks the earrings may be removed; however, some type of post earring must be worn at all times during the first year.

Inactive Ingredient

Purified water.

Questions?

Call 1-800-255-8556

Representative Labeling

Label
KIT
INVERNESS EAR CARE ANTISEPTIC 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60112-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60112-010-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/201401/01/2020
2NDC:60112-010-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/201401/01/2020
3NDC:60112-010-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/201401/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/201401/01/2020
Labeler - Inverness Corp (010968840)

Revised: 11/2019
 
Inverness Corp