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SPL v4

SPL

SPL Set ID a1bd4b93-3b8d-56cf-e053-2995a90a981a

Route

TOPICAL

Published

Effective Date 2020-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (28.93 mL)

Inactive Ingredients

Lavender Oil Water Aloe Vera Leaf Edetol Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-27

Description

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70% v/v

Uses

Hand sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50566-9

Discontinue if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Section 50567-7

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Questions

☎323-728-8555

Directions

Place enough product in your palm to thoroughly cover your hands.
Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

In children less than 2 month of age
On open skin wounds

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Other Information

Store between 15-30˚C (59-86˚F)
Avoid freezing and excessive heat above 40˚C (104˚F)
May discolor certain fabrics.

Inactive Ingredients

Water, Tetrahydroxypropyl Ethylenediamine, Carbomer, Alpha Tocopherol Acetate, Lavandula Angustifolia (Lavender) Oil,

Aloe Barbadensis Leaf Extract

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Discontinue if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Questions

☎323-728-8555

Directions

Place enough product in your palm to thoroughly cover your hands.
Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

In children less than 2 month of age
On open skin wounds

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Other Information (Other information)

Store between 15-30˚C (59-86˚F)
Avoid freezing and excessive heat above 40˚C (104˚F)
May discolor certain fabrics.

Inactive Ingredients

Water, Tetrahydroxypropyl Ethylenediamine, Carbomer, Alpha Tocopherol Acetate, Lavandula Angustifolia (Lavender) Oil,

Aloe Barbadensis Leaf Extract

Advanced Ingredient Data

[{"name": "LAVENDER OIL", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "28.93", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETOL", "unii": "Q4R969U9FR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.", "50566-9": "Discontinue if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.", "50567-7": "When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Questions": "☎323-728-8555", "Directions": "Place enough product in your palm to thoroughly cover your hands. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Do not use": "In children less than 2 month of age On open skin wounds", "Active Ingredient": "Ethyl alcohol 70% v/v", "Other information": "Store between 15-30˚C (59-86˚F) Avoid freezing and excessive heat above 40˚C (104˚F) May discolor certain fabrics.", "Inactive Ingredients": "Water, Tetrahydroxypropyl Ethylenediamine, Carbomer, Alpha Tocopherol Acetate, Lavandula Angustifolia (Lavender) Oil, Aloe Barbadensis Leaf Extract"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:42.590770 · Updated: 2026-03-14T22:56:56.523889