0745c197-f6e8-4ccc-aeaf-6cf96bc09141

SPL v2

SPL

SPL Set ID 0745c197-f6e8-4ccc-aeaf-6cf96bc09141

Route

topical

Published

Effective Date 2020-07-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (70 mL)

Inactive Ingredients

glycerin carbomer interpolymer type a (allyl sucrose crosslinked) aminomethylpropanol tea tree oil aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-21

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 70%

Medication Information

Warnings

Flammable, Keep away from fire or flame. For external use only.

When using this product

• do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation or redness develops.

Uses

TO REDUCE BACTERIA ON SKIN

Purpose

ANTISEPTIC

Directions

Apply small amounts to hands

rub hands together vigorously until dry
supervise children in the use of this product.

Inactive Ingredients

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice

Description

ETHYL ALCOHOL 70%

Section 50565-1

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

Section 51945-4

Active Ingredients

ETHYL ALCOHOL 70%

Structured Label Content

Warnings (WARNINGS)

Flammable, Keep away from fire or flame. For external use only.

When using this product

• do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation or redness develops.

Uses (USES)

TO REDUCE BACTERIA ON SKIN

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

Apply small amounts to hands

rub hands together vigorously until dry
supervise children in the use of this product.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

ETHYL ALCOHOL 70%

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": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "TO REDUCE BACTERIA ON SKIN", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "PURPOSE": "ANTISEPTIC", "WARNINGS": "Flammable, Keep away from fire or flame. For external use only. When using this product • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if • irritation or redness develops.", "DIRECTIONS": "Apply small amounts to hands rub hands together vigorously until dry supervise children in the use of this product.", "ACTIVE INGREDIENTS": "ETHYL ALCOHOL 70%", "INACTIVE INGREDIENTS": "Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:06.677047 · Updated: 2026-03-14T22:57:30.442086