70% Isopropyl Alcohol Antiseptic

70% Isopropyl Alcohol Antiseptic
SPL v3
SPL
SPL Set ID af5febcd-b462-4574-e053-2995a90aabf7
Route
TOPICAL
Published
Effective Date 2020-03-28
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 NOT FINAL Active Since 2020-09-15

Description

This is a first aid antiseptic. The product is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients. Isopropyl Alcohol (70%, v/v) in an aqueous solution. Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

This is a first aid antiseptic. The product is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients. Isopropyl Alcohol (70%, v/v) in an aqueous solution. Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients.

Use

Use(s) helps prevent the risk of infection in: minor cuts, scrapes, burns

Section 42229-5

This is a first aid antiseptic. The product is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients.

  • Isopropyl Alcohol (70%, v/v) in an aqueous solution.
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, do not inhale, do not apply over large areas of the body, do not use longer than 1 week.



Stop use and ask a doctor if condition persists or get worse.



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

Warnings

For external use only. Flammable. Keep away from fire or flame, heat, spark, electrical

Directions

clean the affected area, apply a small amount of this product on the area 1 to 3 times daily, may be covered with a sterile bandage, if bandaged, let dry first

Other Information
  • does not contain nor is intended as a substitute for grain or ethyl alcohol
  • will produce serious gastric disturbances if taken internally
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

purified water USP

Package Label Principal Display Panel

946 ml NDC: 74793-0008-1


Structured Label Content

Use

Use(s) helps prevent the risk of infection in: minor cuts, scrapes, burns

Section 42229-5 (42229-5)

This is a first aid antiseptic. The product is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients.

  • Isopropyl Alcohol (70%, v/v) in an aqueous solution.
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, do not inhale, do not apply over large areas of the body, do not use longer than 1 week.



Stop use and ask a doctor if condition persists or get worse.



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

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from fire or flame, heat, spark, electrical

Directions

clean the affected area, apply a small amount of this product on the area 1 to 3 times daily, may be covered with a sterile bandage, if bandaged, let dry first

Other Information (Other information)
  • does not contain nor is intended as a substitute for grain or ethyl alcohol
  • will produce serious gastric disturbances if taken internally
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

purified water USP

Package Label Principal Display Panel (Package Label - Principal Display Panel)

946 ml NDC: 74793-0008-1


Advanced Ingredient Data


Raw Label Data

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