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NDC 63736-0327-24 Auro Dri 95 mL/100mL Details

Auro Dri 95 mL/100mL

Auro Dri is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	63736-0327
Product ID	63736-327_c540e5e0-8ba7-4c0f-b333-290fde2cef65
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	Auro Dri
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	AURICULAR (OTIC)
Active Ingredient Strength	95
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Insight Pharmaceuticals LLC
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 63736-0327-24 (63736032724)

Pricing Information	N/A
NDC Package Code	63736-327-24
Billing NDC	63736032724
Package	24 BOX in 1 CASE (63736-327-24) / 1 BOTTLE in 1 BOX / 29 mL in 1 BOTTLE
Marketing Start Date	2010-06-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 85cb4973-6a81-4d8f-b187-4bf709d93a98 Details

SPL UNCLASSIFIED SECTION

AURO-DRI ®

Drug Facts

Active ingredient

Isopropyl alcohol 95% in an anhydrous glycerin 5% base

Purpose

Ear drying aid

Use

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

Do not use

in the eyes

Ask a doctor before use if you have

ear drainage or discharge
pain, irritation or rash in the 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

unscrew cap from bottle
remove foil safety seal from bottle
affix applicator cap to bottle
remove red applicator cap tip
apply 4 to 5 drops in each affected ear

Other information

recap bottle after each use
keep away from heat or direct sunlight
store at room temperature 15° – 25°C (59° – 77°F)
do not use if foil seal imprinted with "SEALED FOR YOUR PROTECTION" under cap is broken or missing
keep carton for full drug facts

Inactive ingredient

glycerin

Questions?

1-800-344-7239 Aurodri.com

PRINCIPAL DISPLAY PANEL

29.6 mL Bottle Carton

AURO- DRI®

ISOPROPYL ALCOHOL 95% in an

ANHYDROUS GLYCERIN 5% base

– Ear Drying Aid

CLEARS WATER FROM

SWIMMERS' EARS

1 FL OZ (29.6 mL)

INGREDIENTS AND APPEARANCE

AURO DRI

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-327
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	95 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	WHITE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63736-327-24	24 in 1 CASE	06/14/2010
1		1 in 1 BOX
1		29 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:63736-327-12	12 in 1 CASE	06/14/2010
2		1 in 1 BOX
2		29 mL in 1 BOTTLE; 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	06/14/2010

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020

Document Id: c540e5e0-8ba7-4c0f-b333-290fde2cef65

Set id: 85cb4973-6a81-4d8f-b187-4bf709d93a98

Version: 4

Effective Time: 20200110