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SPL v1

SPL

SPL Set ID 2992a52a-21a9-18be-e063-6294a90a834d

Route

TOPICAL

Published

Effective Date 2024-12-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Calendula Officinalis Flower Water Aloe Barbadensis Leaf Juice Glycerin Chamomile

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

• For hand washing to decrease bacteria on skin.

Section 51945-4

Warnings

For external use only.

Flammable.

Keep away from sources of fire or flame

Directions

Apply onto palm of hand

Cover hands with product by thoroughly rubbing and allow to air dry without wiping

Use undiluted

Supervise children under 6 years.

Not recommended for infants

Other Information

Store below 86° F/30° C

Keep out of direct sunlight

Active Ingredients

Ethyl Alcohol 62%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance*, Glycerin, Water

*Comprised of natural, raw, aromatic materials

When Using This Product

do not use near eyes. In case of contact, rinse eyes thoroughly with water.

Stop and Ask A Doctor If

skin irritation develops.

Keep Out of Reach of Children.

If swallowed, seek medical advice or contact a Poison Control Center immediately.

Structured Label Content

Uses

• For hand washing to decrease bacteria on skin.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only.

Flammable.

Keep away from sources of fire or flame

Directions

Apply onto palm of hand

Cover hands with product by thoroughly rubbing and allow to air dry without wiping

Use undiluted

Supervise children under 6 years.

Not recommended for infants

Other Information (Other information)

Store below 86° F/30° C

Keep out of direct sunlight

Active Ingredients (Active ingredients)

Ethyl Alcohol 62%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance*, Glycerin, Water

*Comprised of natural, raw, aromatic materials

When Using This Product (When using this product)

do not use near eyes. In case of contact, rinse eyes thoroughly with water.

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

skin irritation develops.

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

If swallowed, seek medical advice or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE BARBADENSIS LEAF JUICE", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• For hand washing to decrease bacteria on skin.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from sources of fire or flame", "Directions": "Apply onto palm of hand Cover hands with product by thoroughly rubbing and allow to air dry without wiping Use undiluted Supervise children under 6 years. Not recommended for infants", "Other information": "Store below 86° F/30° C Keep out of direct sunlight", "Active ingredients": "Ethyl Alcohol 62%", "Inactive ingredients": "Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance*, Glycerin, Water *Comprised of natural, raw, aromatic materials", "When using this product": "do not use near eyes. In case of contact, rinse eyes thoroughly with water.", "Stop and ask a doctor if": "skin irritation develops.", "Keep out of reach of children.": "If swallowed, seek medical advice or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:01.069503 · Updated: 2026-03-14T23:06:16.981214