Foaming Hand Sanitizer

SPL v1

SPL

SPL Set ID da33a6ff-92f3-942f-e053-2995a90aa0db

Route

TOPICAL

Published

Effective Date 2022-03-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dehydrated Alcohol (0.7 mg)

Inactive Ingredients

Aloe Vera Leaf Water Peg-10 Acrylate/perfluorohexylethyl Acrylate Copolymer D&c Green No. 5 2-(perfluorohexyl)ethanol Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2022-03-02

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Uses

Hand sanitizer to reduce microorganisms on the skin.

Use this product when soap and water are not available.

Label

Warnings

For external use only. FLAMMABLE. This product contains ethyl alcohol.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Read entire label before using this product.

Place a palmful (5 grams) of product in one hand.

Spread on both handsand rub into the skin until dry (1-2 min).

Active Ingredient

Ethyl Alcohol 70% v/v

Inactive Ingredients

Aloe Barbadensis Leaf Juice, D&C Green #5, Fragrance, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, Perfluorohexylethyl Alcohol, Propylene Glycol, Water

Keep Out of Reach of Children

Keep out of the reach of children

Structured Label Content

Uses

Hand sanitizer to reduce microorganisms on the skin.

Use this product when soap and water are not available.

Label

Purpose

Antiseptic

Warnings

For external use only. FLAMMABLE. This product contains ethyl alcohol.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Read entire label before using this product.

Place a palmful (5 grams) of product in one hand.

Spread on both handsand rub into the skin until dry (1-2 min).

Active Ingredient (Active ingredient)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Aloe Barbadensis Leaf Juice, D&C Green #5, Fragrance, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, Perfluorohexylethyl Alcohol, Propylene Glycol, Water

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of the reach of children

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER", "unii": "D76Z87928N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C GREEN NO. 5", "unii": "8J6RDU8L9X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-(PERFLUOROHEXYL)ETHANOL", "unii": "G2R5YO5N3V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEHYDRATED ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to reduce microorganisms on the skin. Use this product when soap and water are not available.", "Purpose": "Antiseptic", "Warnings": "For external use only. FLAMMABLE. This product contains ethyl alcohol. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Read entire label before using this product. Place a palmful (5 grams) of product in one hand. Spread on both handsand rub into the skin until dry (1-2 min).", "Active ingredient": "Ethyl Alcohol 70% v/v", "Inactive Ingredients": "Aloe Barbadensis Leaf Juice, D&C Green #5, Fragrance, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, Perfluorohexylethyl Alcohol, Propylene Glycol, Water", "Keep out of reach of children": "Keep out of the reach of children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:08.966502 · Updated: 2026-03-14T23:00:30.367061