onyx advanced hand sanitizer

SPL v1

SPL

SPL Set ID a3d73e4f-893e-6668-e053-2a95a90a6592

Route

topical

Published

Effective Date 2020-04-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (0.7 mL)

Inactive Ingredients

water glycerin carbomer homopolymer, unspecified type trolamine dmdm hydantoin iodopropynyl butylcarbamate butylene glycol

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-01

Purpose

Antimicrobial

Description

Ethyl alcohol 70% v/v

Medication Information

Warnings

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

Purpose

Antimicrobial

Description

Ethyl alcohol 70% v/v

Use:

Hand sanitizer to help reduce bacteria on the skin.

Do Not

ingest, if swallowed seek medical help. Avoid contact with eyes.

Directions:

Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

Active Ingredient

Ethyl alcohol 70% v/v

Package Labeling:

Other Information:

Store below 106°F (41°C).

May discolor certain fabrics or surfaces.

Inactive Ingredients:

demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Keep Out of Reach of Children.

Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

Structured Label Content

Warnings

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

Purpose

Antimicrobial

Use:

Hand sanitizer to help reduce bacteria on the skin.

Do Not (Do not )

ingest, if swallowed seek medical help. Avoid contact with eyes.

Directions:

Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

Active Ingredient (Active ingredient)

Ethyl alcohol 70% v/v

Package Labeling:

Other Information: (Other information:)

Store below 106°F (41°C).

May discolor certain fabrics or surfaces.

Inactive Ingredients: (Inactive ingredients:)

demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Keep Out of Reach of Children. (Keep out of reach of children.)

Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODOPROPYNYL BUTYLCARBAMATE", "unii": "603P14DHEB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use:": "Hand sanitizer to help reduce bacteria on the skin.", "Purpose": "Antimicrobial", "Do not ": "ingest, if swallowed seek medical help. Avoid contact with eyes.", "Warnings": "Flammable. Keep away from fire or flame. For external use only.", "Directions:": "Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.", "Active ingredient": "Ethyl alcohol 70% v/v", "Other information:": "Store below 106°F (41°C). May discolor certain fabrics or surfaces.", "Inactive ingredients:": "demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.", "Keep out of reach of children.": "Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:17.373578 · Updated: 2026-03-14T22:56:19.866300