Hand Sanitizer

SPL v2

SPL

SPL Set ID 9268a885-9bf4-45a3-9134-23f9e08eedb4

Route

TOPICAL

Published

Effective Date 2020-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water Glycerin Propylene Glycol Carbomer Homopolymer, Unspecified Type Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-20

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

Drug Facts

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.

Warnings

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

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.

Do Not Use

In children less than 2 months age
On open wounds

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Active Ingredients

Alcohol 70% v/v

Inactive Ingredients

Aqua (Water), Glycerin, Propylene Glycol, Carbomer, Triethanolamine.

Questions Or Comments

Call toll free 1-800-366-7254

Principal Display Panel 100 Ml Bottle Label

Alcohol Gel

Hand Sanitizer

Alcohol Antiseptic 70%

Topical Solution

Non-sterile Solution

100 ml ℮ 3.4 fl.oz

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

Drug Facts

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.

Purpose

Antiseptic

Warnings

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

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.

Do Not Use (Do not use)

In children less than 2 months age
On open wounds

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Active Ingredients (Active ingredients)

Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Glycerin, Propylene Glycol, Carbomer, Triethanolamine.

Questions Or Comments (Questions or comments)

Call toll free 1-800-366-7254

Principal Display Panel 100 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label)

Alcohol Gel

Hand Sanitizer

Alcohol Antiseptic 70%

Topical Solution

Non-sterile Solution

100 ml ℮ 3.4 fl.oz

Advanced Ingredient Data

[{"name": "Alcohol", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Carbomer Homopolymer, Unspecified Type", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "42229-5": "Drug Facts", "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 occurs. These may be signs of a serious condition.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "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.", "Do not use": "In children less than 2 months age On open wounds", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Active ingredients": "Alcohol 70% v/v", "Inactive ingredients": "Aqua (Water), Glycerin, Propylene Glycol, Carbomer, Triethanolamine.", "Questions or comments": "Call toll free 1-800-366-7254", "PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label": "Alcohol Gel Hand Sanitizer Alcohol Antiseptic 70% Topical Solution Non-sterile Solution 100 ml ℮ 3.4 fl.oz"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:25.618995 · Updated: 2026-03-14T22:56:35.991862