drug facts

drug facts

SPL v1

SPL

SPL Set ID e2fba421-badb-4d87-aec4-01a36828bbde

Route

topical

Published

Effective Date 2020-03-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (650 mg)

Inactive Ingredients

water isopropyl alcohol glycerin isopropyl myristate aloe vera leaf .alpha.-tocopherol acetate, dl- carbomer 934 aminomethylpropanol

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-16

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Medication Information

Warnings

For external use only.

Flammable
Keep away from source of heat or fire

Uses

to help reduce bacteria on the skin.

Purpose

Antiseptic

Directions

put enough product in your palm to cover hands and rub hands together until dry.
children under 6 years should be supervised when using this product.

Other Information

store at a temperature below 110°F (43°C)
may discolor certain fabrics or surfaces

Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Description

Ethyl Alcohol 65%

Active Ingredient

Ethyl Alcohol 65%

Label Copy 2 Fl Oz

Label Copy 8 Fl Oz

Label Copy 32 Fl Oz

Label Copy 40 Fl Oz

Questions Or Comments?

1-866-695-3030

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If

irritation or redness develops and lasts.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only.

Flammable
Keep away from source of heat or fire

Uses

to help reduce bacteria on the skin.

Purpose

Antiseptic

Directions

put enough product in your palm to cover hands and rub hands together until dry.
children under 6 years should be supervised when using this product.

Other Information (Other information)

store at a temperature below 110°F (43°C)
may discolor certain fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Label Copy 2 Fl Oz (Label copy 2 fl oz)

Label Copy 8 Fl Oz (Label copy 8 fl oz)

Label Copy 32 Fl Oz (Label copy 32 fl oz)

Label Copy 40 Fl Oz (Label copy 40 fl oz)

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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

irritation or redness develops and lasts.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to help reduce bacteria on the skin.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable Keep away from source of heat or fire", "Directions": "put enough product in your palm to cover hands and rub hands together until dry. children under 6 years should be supervised when using this product.", "Active ingredient": "Ethyl Alcohol 65%", "Other information": "store at a temperature below 110°F (43°C) may discolor certain fabrics or surfaces", "Inactive ingredients": "Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).", "Questions or comments?": "1-866-695-3030", "When using this product": "avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "Stop use and ask a doctor if": "irritation or redness develops and lasts.", "Keep out of reach of children.": "In case of accidental ingestion, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:04.277464 · Updated: 2026-03-14T22:55:59.360416