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SPL v1

SPL

SPL Set ID a19a9f11-9286-199a-e053-2995a90a94ad

Route

EXTRACORPOREAL

Published

Effective Date 2020-03-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (41.3 mL)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Yellow No. 5 Propylene Glycol Isopropyl Alcohol .alpha.-tocopherol Acetate Carbomer Homopolymer, Unspecified Type Aloe Vera Leaf Caprylyl Glycol Glycerin Aminomethylpropanol Water

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-19

Description

1.5m1-3 5ml/time; Store below 110°F (43°C) ; May discolor certain fabrics of surfaces

Medication Information

Warnings and Precautions

keep out of reach of childen

Indications and Usage

Take appropriate amount of this product to moisten your hands and rub for one minute until the liquid covers the whole surface

Dosage and Administration

1.5m1-3 5ml/time; Store below 110°F (43°C) ; May discolor certain fabrics of surfaces

Description

1.5m1-3 5ml/time; Store below 110°F (43°C) ; May discolor certain fabrics of surfaces

Section 50565-1

keep out oreeceh of cildlen

Section 51727-6

Water, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Glycerin, Propylene Glycol ,Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Ethyl alcohol

Structured Label Content

Indications and Usage (34067-9)

Take appropriate amount of this product to moisten your hands and rub for one minute until the liquid covers the whole surface

Dosage and Administration (34068-7)

1.5m1-3 5ml/time; Store below 110°F (43°C) ; May discolor certain fabrics of surfaces

Warnings and Precautions (34071-1)

keep out of reach of childen

Section 50565-1 (50565-1)

keep out oreeceh of cildlen

Section 51727-6 (51727-6)

Water, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Glycerin, Propylene Glycol ,Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

Ethyl alcohol

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "41.3", "strengthDenominator": "59", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Take appropriate amount of this product to moisten your hands and rub for one minute until the liquid covers the whole surface", "34068-7": "1.5m1-3 5ml/time; Store below 110°F (43°C) ; May discolor certain fabrics of surfaces", "34071-1": "keep out of reach of childen", "50565-1": "keep out oreeceh of cildlen", "51727-6": "Water, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Glycerin, Propylene Glycol ,Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol", "55105-1": "Disinfection Sterilization No Rinseing", "55106-9": "Ethyl alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:05.090843 · Updated: 2026-03-14T22:56:00.983918