43116-030 - DailyMed Details

43116-030

SPL v1

SPL

SPL Set ID ef25879d-043f-a751-e053-2a95a90a22c8

Route

TOPICAL

Published

Effective Date 2022-12-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water Trolamine Carbomer Homopolymer, Unspecified Type Glycerin Alpha-tocopherol Acetate Aloe Vera Leaf Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2022-12-06

Description

Ethyl Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Uses

- hand sanitizer to help reduce bacteria that potentially can cause disease

- for use when soap and water are not available

Section 51945-4

Warnings

Flammable, keep away from fire/flame

For external use only

Directions

wet hands thoroughly with product and allow to dry without wiping

supervise children under 6 years of age when using this product

Do Not Use

- in the eyes

- on children less than 2 years of age

- on open skin wounds

Active Ingredient

Ethyl Alcohol 75%

Other Information

- Other information a store between 15-30°C (59-86F)

- avoid freeing and excessive heat above 40°C (104F)

Inactive Ingredients

Aloe (Aloe barbadensis) Leaf Juice, Carbomer , Glycerin , Propylene Glycol , Tocopheryl Acetate ,Triethanolamine , Water

When Using This Product

keep out of eyes, ears, and mouth. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor If

- irritation and redness develop

- condition persists for more than 72 hours

Keep Out of Reach of Children

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

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 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

Flammable, keep away from fire/flame

For external use only

Directions

wet hands thoroughly with product and allow to dry without wiping

supervise children under 6 years of age when using this product

Do Not Use (Do not use)

- in the eyes

- on children less than 2 years of age

- on open skin wounds

Active Ingredient

Ethyl Alcohol 75%

Other Information (Other information)

- Other information a store between 15-30°C (59-86F)

- avoid freeing and excessive heat above 40°C (104F)

Inactive Ingredients (Inactive ingredients)

Aloe (Aloe barbadensis) Leaf Juice, Carbomer , Glycerin , Propylene Glycol , Tocopheryl Acetate ,Triethanolamine , Water

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

- irritation and redness develop

- condition persists for more than 72 hours

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.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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", "Purpose": "Antiseptic", "Warnings": "Flammable, keep away from fire/flame For external use only", "Directions": "wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product", "Do not use": "- in the eyes - on children less than 2 years of age - on open skin wounds", "Active Ingredient": "Ethyl Alcohol 75%", "Other information": "- Other information a store between 15-30°C (59-86F) - avoid freeing and excessive heat above 40°C (104F)", "Inactive ingredients": "Aloe (Aloe barbadensis) Leaf Juice, Carbomer , Glycerin , Propylene Glycol , Tocopheryl Acetate ,Triethanolamine , Water", "When using this product": "keep out of eyes, ears, and mouth. In case of contact, rinse thoroughly with water.", "Stop use and ask a doctor if": "- irritation and redness develop - condition persists for more than 72 hours", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:25.448177 · Updated: 2026-03-14T23:00:51.196726