Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 4f5d9224-63d8-4256-a5ea-b2d16ccbb89b
Route
TOPICAL
Published
Effective Date 2019-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-01-04

Description

Isopropyl Alcohol 70% v/v


Medication Information

Warnings and Precautions

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.

Indications and Usage



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

Dosage and Administration

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.

Description

Isopropyl Alcohol 70% v/v

Section 44425-7

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

Section 50565-1

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

Section 51727-6

Purified water

Section 51945-4

NDC 68356-117-02 PRODUCT # 117-02U





LORIS - ALCOHOL SWABS





MEDIUM

Saturated with 70% v/v isopropyl alcohol, USP

Single use only ● For external use only ● Easy to use ● Economical

Antiseptic

Non-Sterile Solution and Swab





200 units

Section 53413-1

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

Section 55105-1

Antiseptic

Section 55106-9

Isopropyl Alcohol 70% v/v


Structured Label Content

Indications and Usage (34067-9)



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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Purified water

Section 51945-4 (51945-4)

NDC 68356-117-02 PRODUCT # 117-02U





LORIS - ALCOHOL SWABS





MEDIUM

Saturated with 70% v/v isopropyl alcohol, USP

Single use only ● For external use only ● Easy to use ● Economical

Antiseptic

Non-Sterile Solution and Swab





200 units

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Isopropyl Alcohol 70% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)