47993-233 - DailyMed Details

47993-233

SPL v4

SPL

SPL Set ID a37d03b1-e9f2-284c-e053-2995a90a285a

Route

TOPICAL

Published

Effective Date 2020-04-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (12 g)

Inactive Ingredients

Fd&c Blue No. 1 Carbomer 940 Aloe Vera Leaf Glycerin Water Amaranth Triethanolamine Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-17

Description

Active ingredients Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings:

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

Indications and Usage

Uses：

Hand sanitizer to help decrease bacteria on the skin.

When water, soap & towel are not available.

Recommended for repeated use.

Dosage and Administration

Directions:

Pump as needed into your palms and thoroughly spread on both hands.

Rub into skin until dry.

Description

Active ingredients Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children，Children must be supervised in use of this product.

Section 50567-7

When using this product，avoid contact with eyes. In case of contact flush eyes with water.

Section 50569-3

Stop use and as a doctor if redness or irritation develop and persist for more than 72 hours.

Section 50570-1

Do not apply around eyes. Do not use in ears & mouth.

Section 51727-6

Inactive Ingredients:

Water,Carbomer 940,Triethanolamine,Glycerin,Aloe barbadensis leaf juice,Fragrance,CI16185,CI42090

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 62%

Section 60561-8

Store at 20 ℃（68 to77℉）

May discolor fabrics.

Structured Label Content

Indications and Usage (34067-9)

Uses：

Hand sanitizer to help decrease bacteria on the skin.

When water, soap & towel are not available.

Recommended for repeated use.

Dosage and Administration (34068-7)

Directions:

Pump as needed into your palms and thoroughly spread on both hands.

Rub into skin until dry.

Warnings and Precautions (34071-1)

Warnings:

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

Section 50565-1 (50565-1)

Keep out of reach of children，Children must be supervised in use of this product.

Section 50567-7 (50567-7)

When using this product，avoid contact with eyes. In case of contact flush eyes with water.

Section 50569-3 (50569-3)

Stop use and as a doctor if redness or irritation develop and persist for more than 72 hours.

Section 50570-1 (50570-1)

Do not apply around eyes. Do not use in ears & mouth.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Carbomer 940,Triethanolamine,Glycerin,Aloe barbadensis leaf juice,Fragrance,CI16185,CI42090

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Store at 20 ℃（68 to77℉）

May discolor fabrics.

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "12", "strengthDenominator": "112", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "112", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "112", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMARANTH", "unii": "37RBV3X49K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE BENZOATE", "unii": "M3EN4GC19W", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "112", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "112", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses： Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.", "34068-7": "Directions: Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.", "34071-1": "Warnings: For external use only. Flammable. Keep away from fire or flame.", "50565-1": "Keep out of reach of children，Children must be supervised in use of this product.", "50567-7": "When using this product，avoid contact with eyes. In case of contact flush eyes with water.", "50569-3": "Stop use and as a doctor if redness or irritation develop and persist for more than 72 hours.", "50570-1": "Do not apply around eyes. Do not use in ears & mouth.", "51727-6": "Inactive Ingredients: Water,Carbomer 940,Triethanolamine,Glycerin,Aloe barbadensis leaf juice,Fragrance,CI16185,CI42090", "55105-1": "Antiseptic", "55106-9": "Active ingredients Ethyl Alcohol 62%", "60561-8": "Store at 20 ℃（68 to77℉） May discolor fabrics."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:59.636707 · Updated: 2026-03-14T22:58:47.860892