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SPL v1

SPL

SPL Set ID 06dd2427-097c-b0fa-e063-6294a90a4f82

Route

TOPICAL

Published

Effective Date 2023-10-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Aminomethylpropanol Water Carbomer Homopolymer, Unspecified Type Glycerin Propylene Glycol .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-04

Description

Ethyl Alcohol 70.0%v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70.0%v/v

Uses

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Label

Warnings

For external use only

Flammable, keep away from heat and flame.

Directions

wet hands thoroughly with product

Briskly rub hands together until dry

Supervise children under 6 years in the use of this product

Do Not Use

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water

Active Ingredient

Ethyl Alcohol 70.0%v/v

Other Information

Store at room temperature

May discolor certain fabrics

Inactive Ingredients

water

carbomer

glycerin

propylene glycol

aminomethyl propanol

fragrance

aloe barbadensis leaf juice

tocopheryl acetate

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation and redness develop and persist 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

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Label (label)

Purpose

Antimicrobial

Warnings

For external use only

Flammable, keep away from heat and flame.

Directions

wet hands thoroughly with product

Briskly rub hands together until dry

Supervise children under 6 years in the use of this product

Do Not Use (Do not use)

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water

Active Ingredient (Active ingredient)

Ethyl Alcohol 70.0%v/v

Other Information (Other information)

Store at room temperature

May discolor certain fabrics

Inactive Ingredients (Inactive ingredients)

water

carbomer

glycerin

propylene glycol

aminomethyl propanol

fragrance

aloe barbadensis leaf juice

tocopheryl acetate

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

Stop use and ask a doctor if irritation and redness develop and persist 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": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "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": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin Recommended for repeated use", "Purpose": "Antimicrobial", "Warnings": "For external use only Flammable, keep away from heat and flame.", "Directions": "wet hands thoroughly with product Briskly rub hands together until dry Supervise children under 6 years in the use of this product", "Do not use": "Do not use in the eyes. In case of contact, rinse eyes thoroughly with water", "Active ingredient": "Ethyl Alcohol 70.0%v/v", "Other information": "Store at room temperature May discolor certain fabrics", "Inactive ingredients": "water carbomer glycerin propylene glycol aminomethyl propanol fragrance aloe barbadensis leaf juice tocopheryl acetate", "Stop use and ask a doctor if": "Stop use and ask a doctor if irritation and redness develop and persist 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

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Source: dailymed · Ingested: 2026-02-15T12:01:18.380908 · Updated: 2026-03-14T23:01:21.342577