a6acd1d9-4fae-692a-e053-2a95a90a5697

SPL v1

SPL

SPL Set ID a6acd1d9-4fae-692a-e053-2a95a90a5697

Route

topical

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (0.1 1)

Inactive Ingredients

decyl glucoside cetylpyridinium chloride anhydrous didecyldimonium chloride glycerin aloe vera leaf chamaemelum nobile flower oil benzethonium chloride water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-05-27

Purpose

Purpose: Antimicrobial

Description

Ethyl Alcohol 75% v/v.

Medication Information

Warnings

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

Purpose

Purpose: Antimicrobial

Directions

Wipe surface to be disinfected.

Supervise children under 12 years of age when using this product to avoid swallowing.

Other Information

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

Inactive Ingredients

Water Glycerol, Aloe. Vera, Chamomile Oil, D-Glucopyranose, Oligomeric, Benzethonium Chloride, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride

Description

Ethyl Alcohol 75% v/v.

Use

Sanitizer Wipes to help reduce bacteria that 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 a Poison Control Center right away.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do Not Use

On children less than 2 months of age
On open skin wounds

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Package Label Principal Display Panel

300 units NDC:75778-004-30

Structured Label Content

Warnings

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

Purpose

Purpose: Antimicrobial

Directions

Wipe surface to be disinfected.

Supervise children under 12 years of age when using this product to avoid swallowing.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Water Glycerol, Aloe. Vera, Chamomile Oil, D-Glucopyranose, Oligomeric, Benzethonium Chloride, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride

Use

Sanitizer Wipes to help reduce bacteria that 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 a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do Not Use (Do not use)

On children less than 2 months of age
On open skin wounds

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

300 units NDC:75778-004-30

Advanced Ingredient Data

[{"name": "DECYL GLUCOSIDE", "unii": "Z17H97EA6Y", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "CETYLPYRIDINIUM CHLORIDE ANHYDROUS", "unii": "6BR7T22E2S", "classCode": "IACT", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "DIDECYLDIMONIUM CHLORIDE", "unii": "JXN40O9Y9B", "classCode": "IACT", "strengthNumerator": "0.04", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "CHAMAEMELUM NOBILE FLOWER OIL", "unii": "UB27587839", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "BENZETHONIUM CHLORIDE", "unii": "PH41D05744", "classCode": "IACT", "strengthNumerator": "0.08", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "23.73", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "Sanitizer Wipes to help reduce bacteria that 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 a Poison Control Center right away.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Purpose: Antimicrobial", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "Wipe surface to be disinfected. Supervise children under 12 years of age when using this product to avoid swallowing.", "Do not use": "On children less than 2 months of age On open skin wounds", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Active Ingredient(s)": "Ethyl Alcohol 75% v/v.", "Inactive ingredients": "Water Glycerol, Aloe. Vera, Chamomile Oil, D-Glucopyranose, Oligomeric, Benzethonium Chloride, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride", "Package Label - Principal Display Panel": "300 units NDC:75778-004-30"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:46.478402 · Updated: 2026-03-14T22:57:03.157172