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NDC 00168-0126-91 Swim-EAR 950 mg/mL Details

Swim-EAR 950 mg/mL

Swim-EAR is a AURICULAR (OTIC) SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	00168-0126
Product ID	0168-0126_4592e208-4cec-4edb-a704-b1830126451b
Associated GPIs	87400045000950
GCN Sequence Number	014183
GCN Sequence Number Description	isopropyl alcohol in glycerin DROPS 95 %-5 % OTIC (EAR)
HIC3	Q8Y
HIC3 Description	EAR PREPARATIONS, MISCELLANEOUS (OTC)
GCN	88490
HICL Sequence Number	005165
HICL Sequence Number Description	ISOPROPYL ALCOHOL IN GLYCERIN
Brand/Generic	Generic
Proprietary Name	Swim-EAR
Proprietary Name Suffix	n/a
Non-Proprietary Name	Swim-EAR
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	AURICULAR (OTIC)
Active Ingredient Strength	950
Active Ingredient Units	mg/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Fougera Pharmaceuticals Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part344
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00168-0126-91 (00168012691)

Pricing Information
NDC Package Code	0168-0126-91
Billing NDC	00168012691
Package	1 BOTTLE, DROPPER in 1 CARTON (0168-0126-91) / 29.57 mL in 1 BOTTLE, DROPPER
Marketing Start Date	1970-04-03
NDC Exclude Flag	N
Price Per Unit	0.08742
Pricing Unit	ML
Effective Date	2024-01-17
NDC Description	SWIM EAR DROPS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b849acb5-e20b-464c-948b-8dcc51fdaf70 Details

Drug Facts

Active ingredient

Isopropyl alcohol, 95%

Purpose

Ear drying aid

Uses

Dries water in the ears and relieves water-clogged ears after:

•: swimming
•: showering
•: bathing
•: washing the hair.

Warnings

Flammable: Keep away from fire or flame.

SPL UNCLASSIFIED SECTION

Do not use in the eyes.

Ask a doctor before use if you have

•: ear drainage or discharge
•: pain, irritation or rash in ear
•: had ear surgery
•: dizziness

: Stop use and ask a doctor if irritation (too much burning) or pain occurs.

: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply 4 to 5 drops in each affected ear.

Inactive ingredient

Anhydrous glycerin 5% base.

: E. FOUGERA & CO.

A division of

Fougera Pharmaceuticals Inc.

Melville, New York 11747

IP4808C

R10/12

#8

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CONTAINER

NDC 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz Carton

NDC 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)

INGREDIENTS AND APPEARANCE

SWIM-EAR

swim-ear solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0168-0126
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	950 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0168-0126-91	1 in 1 CARTON	04/03/1970
1		29.57 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	04/03/1970

Labeler - Fougera Pharmaceuticals Inc. (043838424)

Revised: 3/2021

Document Id: 4592e208-4cec-4edb-a704-b1830126451b

Set id: b849acb5-e20b-464c-948b-8dcc51fdaf70

Version: 3

Effective Time: 20210329