Ls31 Cummings Rd.

SPL v6

SPL

SPL Set ID a618fda6-824d-ba54-e053-2995a90a85a7

Route

TOPICAL

Published

Effective Date 2020-06-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Hypromelloses Glycerin Water Aminomethylpropanol Methacrylic Acid - Ethyl Acrylate Copolymer (4500 Mpa.s)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-19

Description

Alcohol

Purpose

Antiseptic

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat and open flame.

Indications and Usage

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Antiseptic

Dosage and Administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Description

Alcohol

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do not use on children less than 2 months of age or on open skin wounds.

Section 51727-6

water, acrylates copolymer, glycerin, aminomethyl propanol, hydroxypropyl methylcellulose, fragrance

Active Ingredient

Alcohol

Ls31 Product Labels

263.59 ml: NDC Code 77093-221-01

473.18 ml: NDC Code 77093-221-02

3785ml : NDC Code 77093-221-03

208000ml: NDC Code 77093-221-05

Other Safety Information

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

Structured Label Content

Indications and Usage (34067-9)

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Dosage and Administration (34068-7)

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat and open flame.

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use on children less than 2 months of age or on open skin wounds.

Section 51727-6 (51727-6)

water, acrylates copolymer, glycerin, aminomethyl propanol, hydroxypropyl methylcellulose, fragrance

Purpose (purpose)

Antiseptic

Active Ingredient (active ingredient)

Alcohol

Ls31 Product Labels (LS31 Product Labels)

263.59 ml: NDC Code 77093-221-01

473.18 ml: NDC Code 77093-221-02

3785ml : NDC Code 77093-221-03

208000ml: NDC Code 77093-221-05

Other Safety Information (other safety information)

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

Advanced Ingredient Data

[{"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)", "unii": "T967IEU43C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "34068-7": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "34071-1": "For external use only. Flammable. Keep away from heat and open flame.", "50565-1": "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50567-7": "Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "50570-1": "Do not use on children less than 2 months of age or on open skin wounds.", "51727-6": "water, acrylates copolymer, glycerin, aminomethyl propanol, hydroxypropyl methylcellulose, fragrance", "purpose": "Antiseptic", "active ingredient": "Alcohol", "LS31 Product Labels": "263.59 ml: NDC Code 77093-221-01 473.18 ml: NDC Code 77093-221-02 3785ml : NDC Code 77093-221-03 208000ml: NDC Code 77093-221-05", "other safety information": "Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:21.289911 · Updated: 2026-03-14T22:57:50.764620