b374086c-1ba9-06a1-e053-2995a90a8723

SPL v1
SPL
SPL Set ID b374086c-1ba9-06a1-e053-2995a90a8723
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 2020-10-30

Purpose

Antiseptic

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame. Causes serious eye irritation.

Purpose

Antiseptic

Directions
  • Wipe hands thoroughly, discard after use.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

deionized water

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Use

Hand Sanitizer wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



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



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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

000 ml NDC: 76979-072-01


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame. Causes serious eye irritation.

Purpose

Antiseptic

Directions
  • Wipe hands thoroughly, discard after use.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

deionized water

Use

Hand Sanitizer wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



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



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

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

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

000 ml NDC: 76979-072-01


Advanced Ingredient Data


Raw Label Data

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