SPL v1
SPL
SPL Set ID a8779b2a-0214-ad02-e053-2a95a90a8b27
Route
TOPICAL
Published
Effective Date 2020-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Trolamine Polyacrylic Acid (800000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-19
Description

Ethyl Alcohol 70%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl 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.

Keep the lid of this container tightly closed.

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.



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)

Ethyl Alcohol 70%

Inactive Ingredients

Carpobol 90, T.E.A Triethanolamine, Glycerin

Package Label Principal Display Panel

60 mL NDC:75778-005-60

118 mL NDC:75778-005-11

236 mL NDC:75778-005-23

473 mL NDC:75778-005-47

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.

Keep the lid of this container tightly closed.

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.



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)

Ethyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)

Carpobol 90, T.E.A Triethanolamine, Glycerin

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

60 mL NDC:75778-005-60

118 mL NDC:75778-005-11

236 mL NDC:75778-005-23

473 mL NDC:75778-005-47

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:59.559242 · Updated: 2026-03-14T22:57:20.173282