TOPCARE SWIMMERS EAR DROPS- isopropyl alcohol liquid

TopCare Swimmers Ear Drops by

Drug Labeling and Warnings

TopCare Swimmers Ear Drops by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CVS Ear Drops for Swimmers

Drug Facts

Active Ingredient

Isopropyl Alcohol 95% in anhydrous glycerin

Purpose

Ear drying aid

Use

Dries water in the ears.

Warnings

Flammable: Keep away from fire and 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.

Have had ear surgery.

Dizziness.

Stop use and ask doctor if

Irritation (too much burning) or pain occurs.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

• In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately. 

Directions

Apply 5 to 5 drops in each affected ear..

Other information

Store at room temperature.

Inactive Ingredient

Glycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE SWIMMERS EAR DROPS 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-064
Route of Administration	AURICULAR (OTIC)

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-064-91	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	01/03/2019

Labeler - TOPCO ASSOCIATES (006935977)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	analysis(36800-064) , pack(36800-064) , manufacture(36800-064) , label(36800-064)