a7c82443-169e-190f-e053-2a95a90a90ae

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

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.

Inactive Ingredients

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

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.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.

Inactive Ingredients (Inactive ingredients)

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

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.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.45", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "RAPIDGEL EZ1", "unii": "33JH4A7R2K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SQUALANE", "unii": "GW89575KF9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "To help reduce bacteria on skin.", "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)", "50565-1": "Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.", "50566-9": "Stop use & ask doctor if irritation occurs or redness develops & persists.", "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": "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"}

Additional Information

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