Renowned Premium Gel Hand Sanitizer

SPL v1

SPL

SPL Set ID 24a925b8-92d8-4401-bfc5-d3e476451bac

Route

TOPICAL

Published

Effective Date 2020-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Hydrogen Peroxide Water Trolamine Carbomer Homopolymer, Unspecified Type Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-06-08

Description

Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Use[s]

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

Section 42229-5

Alcohol Antiseptic 70%

Topical Solution

Hand Sanitizer

Non-sterile Solution

Renowned Trading, LLC 18465 FM 362 RD, Waller, TX 77484

Section 50565-1

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

Section 51727-6

Inactive Ingredients glycerin, hydrogen peroxide, purified water, triethanolamine, carbomer, propylene glycol

Warnings

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

Do not use

• in children less than 2 months of age

• on open skin wounds

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

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

Packaging

Directions

• 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.

Drug Facts

Other Information

• Store between 15-30°C (59-86°F)

• Avoid freezing and excessive heat above 40°C (104°F)

Active Ingredient[s]

Alcohol 70% v/v

Structured Label Content

Use[s]

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

Section 42229-5 (42229-5)

Alcohol Antiseptic 70%

Topical Solution

Hand Sanitizer

Non-sterile Solution

Renowned Trading, LLC 18465 FM 362 RD, Waller, TX 77484

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 51727-6 (51727-6)

Inactive Ingredients glycerin, hydrogen peroxide, purified water, triethanolamine, carbomer, propylene glycol

Purpose

Antiseptic

Warnings

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

Do not use

• in children less than 2 months of age

• on open skin wounds

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

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

Packaging

Directions

• 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.

Drug Facts

Other Information

• Store between 15-30°C (59-86°F)

• Avoid freezing and excessive heat above 40°C (104°F)

Active Ingredient[s] (Active ingredient[s])

Alcohol 70% v/v

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use[s]": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "42229-5": "Alcohol Antiseptic 70% Topical Solution Hand Sanitizer Non-sterile Solution Renowned Trading, LLC 18465 FM 362 RD, Waller, TX 77484", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive Ingredients glycerin, hydrogen peroxide, purified water, triethanolamine, carbomer, propylene glycol", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame Do not use • in children less than 2 months of age • on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "Directions": "• 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.", "Other Information": "• Store between 15-30°C (59-86°F) • Avoid freezing and excessive heat above 40°C (104°F)", "Active ingredient[s]": "Alcohol 70% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:52.825936 · Updated: 2026-03-14T22:57:10.859448