bf54e3f6-e4b1-4613-9598-667c41fd47a6

SPL v2

SPL

SPL Set ID bf54e3f6-e4b1-4613-9598-667c41fd47a6

Route

topical

Published

Effective Date 2020-04-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

isopropyl alcohol (75 mL)

Inactive Ingredients

glycerin propylene glycol water carbomer 934 triethanolamine sulfate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-08

Purpose

Antiseptic, Hand Sanitizer

Description

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Pump a small amount into palm of hands
Rub thoroughly over all surface of both hands
Rub hands together briskly untill dry

Other Information

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

Inactive Ingredients

Water, propylene glycol, glycerin, carbomer, triethanolamine

Description

Use

For hand sanitizing to help decrease bacteria on the skin

Recommended for repeated use

Section 42229-5

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 redness develops, or if condition persists for more than 72 hours

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush eyes with water.

Do Not Use

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

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Pump a small amount into palm of hands
Rub thoroughly over all surface of both hands
Rub hands together briskly untill dry

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Water, propylene glycol, glycerin, carbomer, triethanolamine

Use

For hand sanitizing to help decrease bacteria on the skin

Recommended for repeated use

Section 42229-5 (42229-5)

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 redness develops, or if condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush eyes with water.

Do Not Use (Do not use)

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

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE SULFATE", "unii": "MV1V89M17O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand sanitizing to help decrease bacteria on the skin Recommended for repeated use", "42229-5": "NA", "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 redness develops, or if condition persists for more than 72 hours", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush eyes with water.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "Pump a small amount into palm of hands Rub thoroughly over all surface of both hands Rub hands together briskly untill dry", "Do not use": "in children less than 2 months of age on open skin wounds", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Active Ingredient(s)": "Isopropyl Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, propylene glycol, glycerin, carbomer, triethanolamine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:14.425703 · Updated: 2026-03-14T22:56:15.235167