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SPL v1

SPL

SPL Set ID ac57aac3-13d1-627a-e053-2a95a90a10db

Route

TOPICAL

Published

Effective Date 2020-08-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Maltodextrin Aloe Vera Leaf Water Glycerin Propylene Glycol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Trolamine .alpha.-tocopherol Acetate Fd&c Red No. 4

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-08-07

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Children under 6 years of age should be supervised when using this product.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4

Warnings:

Not recommended for infants.

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Active Ingredient

Ethyl Alcohol 62%

Other Information

Do not store above 110 °F, May discolor some fabrics.

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C 10-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, FD&C Red No.4.

Structured Label Content

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Children under 6 years of age should be supervised when using this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings:

Not recommended for infants.

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Active Ingredient

Ethyl Alcohol 62%

Other Information

Do not store above 110 °F, May discolor some fabrics.

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C 10-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, FD&C Red No.4.

Advanced Ingredient Data

[{"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "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.", "50565-1": "Keep out of reach of children. If swallowed, get medical help. Children under 6 years of age should be supervised when using this product.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings:": "Not recommended for infants. Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.", "Directions": "Wet hands thoroughly with product and allow to dry without wiping. .", "Active Ingredient": "Ethyl Alcohol 62%", "Other Information": "Do not store above 110 °F, May discolor some fabrics.", "Inactive Ingredients:": "Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C 10-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, FD&C Red No.4."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:26.032678 · Updated: 2026-03-14T22:57:57.287270