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SPL v1

SPL

SPL Set ID 780eba70-b227-4347-bb06-31a14c54d4df

Route

TOPICAL

Published

Effective Date 2020-06-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.65 mL)

Inactive Ingredients

Water Glycerin Chamaecyparis Obtusa Wood Oil Cupressus Sempervirens Leaf Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-06-25

Description

Ethyl alcohol 65%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl alcohol 65%

Use

To decrease bacteria on skin

Section 50565-1

Keep out of reach of children.

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

Flammable. Keep away from fire or flame.

For external use only

Directions

Wet hands thoroughly with product and allow to dry without wiping

Active Ingredient

Ethyl alcohol 65%

Other Information

Store below 110°F (43°C)
May discolor certain fabrics or surfaces

Inactive Ingredients

Water, Glycerin, Cypress Water, Cypress Essence Oil

Structured Label Content

Use

To decrease bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Antimicrobial

Warnings

Flammable. Keep away from fire or flame.

For external use only

Directions

Wet hands thoroughly with product and allow to dry without wiping

Active Ingredient (Active ingredient)

Ethyl alcohol 65%

Other Information (Other information)

Store below 110°F (43°C)
May discolor certain fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Cypress Water, Cypress Essence Oil

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMAECYPARIS OBTUSA WOOD OIL", "unii": "P2OMP71Y62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CUPRESSUS SEMPERVIRENS LEAF OIL", "unii": "M7QUY89S4O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.65", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "To decrease bacteria on skin", "50565-1": "Keep out of reach of children.", "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": "Antimicrobial", "Warnings": "Flammable. Keep away from fire or flame. For external use only", "Directions": "Wet hands thoroughly with product and allow to dry without wiping", "Active ingredient": "Ethyl alcohol 65%", "Other information": "Store below 110°F (43°C) May discolor certain fabrics or surfaces", "Inactive ingredients": "Water, Glycerin, Cypress Water, Cypress Essence Oil"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:02.488515 · Updated: 2026-03-14T22:57:21.738874