SPL v2
SPL
SPL Set ID b1d0f168-6e54-7f32-e053-2a95a90a7a36
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
Myristyl Lactate Cetyl Lactate Low-substituted Hydroxypropyl Cellulose, Unspecified Limonene, (+)- Glycerin Lauryl Lactate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-29
Description

Isopropyl Alcohol 70%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Isopropyl Alcohol 70%

Use

Hand Sanitizer 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. Do not ingest. In case of contact with eyes, rinse eyes thoroughly with water.

Warnings

For external use only

Flammable. Keep away from heat or flame.

Directions
  • Place enough product on hands to cover all surfaces.
  • Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 70%

Inactive Ingredients

Deionized Water, Glycerin, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Hydroxypropyl Cellulose, Limonene

Package Label Principal Display Panel

60 ml NDC: 80932-001-06

Structured Label Content

Use

Hand Sanitizer 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. Do not ingest. In case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Antimicrobial

Warnings

For external use only

Flammable. Keep away from heat or flame.

Directions
  • Place enough product on hands to cover all surfaces.
  • Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)

Deionized Water, Glycerin, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Hydroxypropyl Cellulose, Limonene

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

60 ml NDC: 80932-001-06

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:04.197853 · Updated: 2026-03-14T23:00:23.363901