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SPL v1

SPL

SPL Set ID 52ae9023-e397-4954-9b53-c69936c9b216

Route

TOPICAL

Published

Effective Date 2020-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (350 mL)

Inactive Ingredients

Water Aloe Glycerin Hyaluronate Sodium Carbomer Homopolymer, Unspecified Type Butylene Glycol Aminomethylpropanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

Ethyl Alcohol 70.0%

Purpose

ANTISEPTIC

Medication Information

Purpose

ANTISEPTIC

Description

Ethyl Alcohol 70.0%

Uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Warnings

▪ FOR EXTERNAL USE ONLY ▪ FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME

When using this product

▪Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ▪ Avoid contact with broken skin ▪ Do not inhale or ingest.

Stop use and ask a doctor if irritation or redness develops.

Directions

▪ DISPENSE ONE TO TWO PUMPS OF SANITIZER ONTO HANDS AND RUB THOROUGHLY UNTIL DRY.

▪ USE AS NEEDED ▪ FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION

▪ NOT RECOMMENDED FOR INFANTS

Active Ingredient

Ethyl Alcohol 70.0%

Other Information

▪ Store below 110 °F(43°C)

▪ May discolor some fabrics

▪ Harmful to wood finishes and plastics

Inactive Ingredients

PURIFIED WATER, ALOE EXTRACT, GLYCERIN, SODIUM HYALURONATE, CARBOMER, BUTYLENE GLYCOL, AMINOMETHYL PROPANOL, FRAGRANCE

Questions Or Comments?

Email : [email protected]

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Package Label.principal Display Panel

Structured Label Content

Uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

▪ FOR EXTERNAL USE ONLY ▪ FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME

When using this product

▪Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ▪ Avoid contact with broken skin ▪ Do not inhale or ingest.

Stop use and ask a doctor if irritation or redness develops.

Directions

▪ DISPENSE ONE TO TWO PUMPS OF SANITIZER ONTO HANDS AND RUB THOROUGHLY UNTIL DRY.

▪ USE AS NEEDED ▪ FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION

▪ NOT RECOMMENDED FOR INFANTS

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70.0%

Other Information

▪ Store below 110 °F(43°C)

▪ May discolor some fabrics

▪ Harmful to wood finishes and plastics

Inactive Ingredients (INACTIVE INGREDIENTS)

PURIFIED WATER, ALOE EXTRACT, GLYCERIN, SODIUM HYALURONATE, CARBOMER, BUTYLENE GLYCOL, AMINOMETHYL PROPANOL, FRAGRANCE

Questions Or Comments? (Questions or Comments?)

Email : [email protected]

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "350", "strengthDenominator": "500", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE", "unii": "V5VD430YW9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Butylene Glycol", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN", "PURPOSE": "ANTISEPTIC", "WARNINGS": "▪ FOR EXTERNAL USE ONLY ▪ FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME When using this product ▪Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ▪ Avoid contact with broken skin ▪ Do not inhale or ingest. Stop use and ask a doctor if irritation or redness develops.", "Directions": "▪ DISPENSE ONE TO TWO PUMPS OF SANITIZER ONTO HANDS AND RUB THOROUGHLY UNTIL DRY. ▪ USE AS NEEDED ▪ FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION ▪ NOT RECOMMENDED FOR INFANTS", "ACTIVE INGREDIENT": "Ethyl Alcohol 70.0%", "Other Information": "▪ Store below 110 °F(43°C) ▪ May discolor some fabrics ▪ Harmful to wood finishes and plastics", "INACTIVE INGREDIENTS": "PURIFIED WATER, ALOE EXTRACT, GLYCERIN, SODIUM HYALURONATE, CARBOMER, BUTYLENE GLYCOL, AMINOMETHYL PROPANOL, FRAGRANCE", "Questions or Comments?": "Email : gajoany@gmail.com", "KEEP OUT OF REACH OF CHILDREN": "If swallowed, get medical help or contact a Poison Control Center right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:44.463897 · Updated: 2026-03-14T22:57:00.206654