Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID bc83231e-5eca-1939-e053-2995a90a6179

Route

TOPICAL

Published

Effective Date 2021-02-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Eucalyptus Oil Pine Needle Oil (pinus Sylvestris) Rosmarinus Officinalis Flowering Top Oil Limonene, (+)- Water Aloe Vera Leaf Linalool, (+/-)-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-02-18

Description

Ethyl Alcohol 70%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70%

Uses:

Helps to reduce bacteria on the skin. For repeat use.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 50567-7

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

• Avoid contact with broken skin.

Section 51945-4

Aevi Wellness, Inc

251 Little Falls Drive

Wilmington, DE 19808

Made in USA

Warnings

For external use only. Flammable, keep away from heat and flame. Do not store above 104ºF/40ºC.

Directions:

Apply all over your hands and allow to dry. Do not rinse off. For children under 6, use only under adult supervision. Not recommended for infants.

Active Ingredient

Ethyl Alcohol 70%

Inactive Ingredients

Aqua (Water), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Pinus Sylvestris Leaf (Nordic Pine) Oil, Eucalyptus Globulus Leaf Oil*, Rosmarinus Officinalis (Rosemary) Oil, Linalool, Limonene.

Structured Label Content

Uses:

Helps to reduce bacteria on the skin. For repeat use.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 50567-7 (50567-7)

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

• Avoid contact with broken skin.

Section 51945-4 (51945-4)

Aevi Wellness, Inc

251 Little Falls Drive

Wilmington, DE 19808

Made in USA

Purpose

Antimicrobial

Warnings

For external use only. Flammable, keep away from heat and flame. Do not store above 104ºF/40ºC.

Directions:

Apply all over your hands and allow to dry. Do not rinse off. For children under 6, use only under adult supervision. Not recommended for infants.

Active Ingredient

Ethyl Alcohol 70%

Inactive Ingredients

Aqua (Water), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Pinus Sylvestris Leaf (Nordic Pine) Oil, Eucalyptus Globulus Leaf Oil*, Rosmarinus Officinalis (Rosemary) Oil, Linalool, Limonene.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PINE NEEDLE OIL (PINUS SYLVESTRIS)", "unii": "5EXL5H740Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSMARINUS OFFICINALIS FLOWERING TOP OIL", "unii": "OXN0D3N28L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Helps to reduce bacteria on the skin. For repeat use.", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.", "50566-9": "Stop use and ask a doctor if skin irritation develops.", "50567-7": "When using this product • Keep out of eyes. In case of contact with eyes, flush thoroughly with water. • Avoid contact with broken skin.", "51945-4": "Aevi Wellness, Inc 251 Little Falls Drive Wilmington, DE 19808 Made in USA", "Purpose": "Antimicrobial", "Warnings": "For external use only. Flammable, keep away from heat and flame. Do not store above 104ºF/40ºC.", "Directions:": "Apply all over your hands and allow to dry. Do not rinse off. For children under 6, use only under adult supervision. Not recommended for infants.", "Active Ingredient": "Ethyl Alcohol 70%", "Inactive Ingredients": "Aqua (Water), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Pinus Sylvestris Leaf (Nordic Pine) Oil, Eucalyptus Globulus Leaf Oil*, Rosmarinus Officinalis (Rosemary) Oil, Linalool, Limonene."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:26.411036 · Updated: 2026-03-14T22:59:24.470306