Hand Sanitizer

SPL v8

SPL

SPL Set ID a6bb7f88-ac9b-4f72-e053-2995a90ac15c

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Trolamine Glycerin Carbomer 1342 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-03-30

Description

SPL Unclassified Section

Purpose

Antimicrobial, Hand Sanitizer

Medication Information

Purpose

Antimicrobial, Hand Sanitizer

Description

SPL Unclassified Section

Use

Hand Sanitizer to help reduce bacteria on the skin.

Section 42229-5

SPL Unclassified Section

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 appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

Warnings

Flammable. Keep away from fire or flame.

For extarnal use only.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Do Not Use

in children less than 2 months of age
on open skin wounds

Other Information

Store below 110F (43C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethanol 70% v/v. Purpose: Antimicrobial

Inactive Ingredients

Water (Aqua), Glycerine, Carbomer, Triethanolamine

Package Label Principal Display Panel

250 mL NDC: 76557-000-02

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin.

Section 42229-5 (42229-5)

SPL Unclassified Section

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 appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

Purpose

Antimicrobial, Hand Sanitizer

Warnings

Flammable. Keep away from fire or flame.

For extarnal use only.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)

in children less than 2 months of age
on open skin wounds

Other Information (Other information)

Store below 110F (43C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethanol 70% v/v. Purpose: Antimicrobial

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerine, Carbomer, Triethanolamine

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

250 mL NDC: 76557-000-02

Advanced Ingredient Data

[{"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 1342", "unii": "809Y72KV36", "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"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer to help reduce bacteria on the skin.", "42229-5": "SPL Unclassified Section", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.", "Purpose": "Antimicrobial, Hand Sanitizer", "Warnings": "Flammable. Keep away from fire or flame. For extarnal use only.", "Directions": "Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.", "Do not use": "in children less than 2 months of age on open skin wounds", "Other information": "Store below 110F (43C) May discolor certain fabrics or surfaces", "Active Ingredient(s)": "Ethanol 70% v/v. Purpose: Antimicrobial", "Inactive ingredients": "Water (Aqua), Glycerine, Carbomer, Triethanolamine", "Package Label - Principal Display Panel": "250 mL NDC: 76557-000-02"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:23.198442 · Updated: 2026-03-14T23:12:36.957432