ISOPROPYL ALCOHOL PREP PAD STERILE- isopropyl alcohol swab

ISOPROPYL ALCOHOL PREP PAD STERILE by

Drug Labeling and Warnings

ISOPROPYL ALCOHOL PREP PAD STERILE by is a Otc medication manufactured, distributed, or labeled by LernaPharm Loris Inc., STERIS Isomedix Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each swab)

Isopropyl Alcohol 70%v/v

Purpose

Antiseptic

Uses

For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection.

Warnings

Flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Tear open individual swab and apply product to the injection site prior to an injection. Rub skin briskly in circular motion from injection site outward.

Other information

Store at room temperature between 59 - 86 0F (15 - 30 0C)

Inactive Ingredients

Purified water

Questions or comments?

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

Principal Display Panel

NDC: 68356-104-03               Product No. 104-03U

Antiseptic Isopropyl Alcohol Pad

LORIS

Antiseptic

Sterile Solution and Swab

Unless package is opened or damaged

200 Units

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL PREP PAD STERILE 
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68356-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68356-104-03	200 in 1 BOX	01/10/2015
1		0.238 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/10/2015

Labeler - LernaPharm Loris Inc. (206940905)

Registrant - LernaPharm Loris Inc. (206940905)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Isomedix Services		205475333	sterilize(68356-104)

Establishment
Name	Address	ID/FEI	Business Operations
LernaPharm Loris Inc.		206940905	manufacture(68356-104) , label(68356-104) , pack(68356-104)