SPL v1
SPL
SPL Set ID a7c82443-169e-190f-e053-2a95a90a90ae
Route
TOPICAL
Published
Effective Date 2020-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.45 mL)
Inactive Ingredients
Glycerin .alpha.-tocopherol Acetate, D- Water Rapidgel Ez1 Squalane Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-27
Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Use

To help reduce bacteria on skin.

Section 43683-2

Section 3:

To help reduce bacteria on skin. (06/2020)

Section 8:

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product. (06/2020)

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Section 50566-9

Stop use & ask doctor if irritation occurs or redness develops & persists.

Section 50567-7

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Warnings

For external use only. Flammable, keep away from source of heat & fire.

Directions

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Package Label Principal Display Panel

60 mL NDC: 78044-100-07

100 mL NDC: 78044-100-01

250 mL NDC: 78044-100-02

500 mL NDC: 78044-100-03

3.785 L NDC: 78044-100-04

208.198 L NDC: 78044-100-05

1003.13 L NDC: 78044-100-06

Structured Label Content

Use

To help reduce bacteria on skin.

Section 43683-2 (43683-2)

Section 3:

To help reduce bacteria on skin. (06/2020)

Section 8:

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product. (06/2020)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Section 50566-9 (50566-9)

Stop use & ask doctor if irritation occurs or redness develops & persists.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable, keep away from source of heat & fire.

Directions

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

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

60 mL NDC: 78044-100-07

100 mL NDC: 78044-100-01

250 mL NDC: 78044-100-02

500 mL NDC: 78044-100-03

3.785 L NDC: 78044-100-04

208.198 L NDC: 78044-100-05

1003.13 L NDC: 78044-100-06

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:52.799216 · Updated: 2026-03-14T22:57:09.544683