SPL v2
SPL
SPL Set ID a8b310ef-c7f5-c7ca-e053-2995a90a5c84
Route
TOPICAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Trolamine Glycerin Carbomer 940 Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24
Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Use

Hand sanitizer to help reduce bacteria that can potencially 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.

Section 51945-4

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use
  • In children less than 2 months of age
  • On open skin wounds.
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.
Other Information
  • Store between 15º - 30ºC (59-86F).
  • Avoid freezing and excessive heat above 40ºC (104F)
Active Ingredients

Ethyl Alcohol 70% v/v

Inactive Ingredients

Glycerin, carbomer, triethanolamine, purified water USP, aloe vera.

Structured Label Content

Use

Hand sanitizer to help reduce bacteria that can potencially 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.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings (WARNINGS)

For external use only. Flammable. Keep away from heat or flame.

Do Not Use (DO NOT USE)
  • In children less than 2 months of age
  • On open skin wounds.
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.
Other Information (OTHER INFORMATION)
  • Store between 15º - 30ºC (59-86F).
  • Avoid freezing and excessive heat above 40ºC (104F)
Active Ingredients

Ethyl Alcohol 70% v/v

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycerin, carbomer, triethanolamine, purified water USP, aloe vera.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:59.603364 · Updated: 2026-03-14T22:57:20.173282