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SPL v3

SPL

SPL Set ID 2bd6249b-f215-7aa9-e063-6394a90a6580

Route

TOPICAL

Published

Effective Date 2025-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Polysorbate 20 Glycerin Polyglyceryl-2 Dipolyhydroxystearate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Alcohol 75% v/v. Purpose: Antimicrobial/Antiseptic

Medication Information

Warnings and Precautions

Flammable. Keep away from fire or flame.

Indications and Usage

Sanitizing wipes to help reduce bacteria on skin. Not intended for use in medical procedures. Recommended for frequent use.

Dosage and Administration

Discard after use

Do not flush

Children under 6 years of age should be supervised when using this product.

Description

Alcohol 75% v/v. Purpose: Antimicrobial/Antiseptic

Section 43685-7

For external use only

Section 44425-7

Store below 110°F (43°C)

May discolor certain surfaces and fabrics

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 appears and lasts.

Section 50567-7

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

Section 51727-6

Purified Water (Aqua), Glycerin, Glyceryl Oleate, Polyglyceryl-2 Dipolyhydroxystearate, Polysorbate 20

Section 51945-4

Section 55105-1

Sanitizing wipes to help reduce bacteria on the skin and surfaces

Not intended for use in medical procedures

Section 55106-9

Alcohol 75% v/v. Purpose: Antimicrobial/Antiseptic

Structured Label Content

Indications and Usage (34067-9)

Sanitizing wipes to help reduce bacteria on skin. Not intended for use in medical procedures. Recommended for frequent use.

Dosage and Administration (34068-7)

Discard after use

Do not flush

Children under 6 years of age should be supervised when using this product.

Warnings and Precautions (34071-1)

Flammable. Keep away from fire or flame.

Section 43685-7 (43685-7)

For external use only

Section 44425-7 (44425-7)

Store below 110°F (43°C)

May discolor certain surfaces and fabrics

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 appears and lasts.

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

Purified Water (Aqua), Glycerin, Glyceryl Oleate, Polyglyceryl-2 Dipolyhydroxystearate, Polysorbate 20

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sanitizing wipes to help reduce bacteria on the skin and surfaces

Not intended for use in medical procedures

Section 55106-9 (55106-9)

Alcohol 75% v/v. Purpose: Antimicrobial/Antiseptic

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE", "unii": "9229XJ4V12", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Sanitizing wipes to help reduce bacteria on skin. Not intended for use in medical procedures. Recommended for frequent use.", "34068-7": "Discard after use Do not flush Children under 6 years of age should be supervised when using this product.", "34071-1": "Flammable. Keep away from fire or flame.", "43685-7": "For external use only", "44425-7": "Store below 110°F (43°C) May discolor certain surfaces and fabrics", "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 appears and lasts.", "50567-7": "When using this product, do not use it in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "51727-6": "Purified Water (Aqua), Glycerin, Glyceryl Oleate, Polyglyceryl-2 Dipolyhydroxystearate, Polysorbate 20", "55105-1": "Sanitizing wipes to help reduce bacteria on the skin and surfaces Not intended for use in medical procedures", "55106-9": "Alcohol 75% v/v. Purpose: Antimicrobial/Antiseptic"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.544274 · Updated: 2026-03-14T23:12:28.058882