Sanigenix 62% Gel Hand Sanitizer

SPL v1

SPL

SPL Set ID ad1ebb3b-6126-1e53-e053-2a95a90a40b0

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (1.45 mL)

Inactive Ingredients

.alpha.-tocopherol Acetate, D- Squalane Rapidgel Ez1 Aloe Vera Leaf Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-08-17

Description

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 62% v/v. Purpose: Antiseptic

Use

To help reduce bacteria on skin.

Section 43683-2

Section 3:

To help reduce bacteria on skin. (08/2020)

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. (08/2020)

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)

Alcohol 62% 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

1L NDC: 78044-400-05

Structured Label Content

Use

To help reduce bacteria on skin.

Section 43683-2 (43683-2)

Section 3:

To help reduce bacteria on skin. (08/2020)

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. (08/2020)

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)

Alcohol 62% 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)

1L NDC: 78044-400-05

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SQUALANE", "unii": "GW89575KF9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RAPIDGEL EZ1", "unii": "33JH4A7R2K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.45", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "To help reduce bacteria on skin.", "43683-2": "Section 3: To help reduce bacteria on skin. (08/2020) 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. (08/2020)", "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)": "Alcohol 62% 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": "1L NDC: 78044-400-05"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:30.181603 · Updated: 2026-03-14T22:58:05.187766