SPL v1
SPL
SPL Set ID 74c98d9d-ee27-48f2-81b2-f36177bca7cf
Route
TOPICAL
Published
Effective Date 2020-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-14

Description

   Alcohol 75% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

   Alcohol 75% v/v.

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Section 50565-1

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

When using this product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest

Stop use and ask a doctor if:

Irritation or redness develops

Condition persists for more than 72 hours.

Directions

Place enough product on hand to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Product  Label

Active Ingredient

   Alcohol 75% v/v.

Other Information
  • Do not store above 105℉

    May discolor some fabrics

    Harmful to wood finishes and plastics
Inactive Ingredients

Purified water


Structured Label Content

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Section 50565-1 (50565-1)

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

When using this product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest

Stop use and ask a doctor if:

Irritation or redness develops

Condition persists for more than 72 hours.

Directions

Place enough product on hand to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Product  Label

Active Ingredient

   Alcohol 75% v/v.

Other Information (Other information)
  • Do not store above 105℉

    May discolor some fabrics

    Harmful to wood finishes and plastics
Inactive Ingredients (Inactive ingredients)

Purified water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)