b00687db-df96-4593-e053-2995a90a5954

SPL v1

SPL

SPL Set ID b00687db-df96-4593-e053-2995a90a5954

Route

topical

Published

Effective Date 2020-09-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (22.5 mL)

Inactive Ingredients

fd&c blue no. 1 d&c red no. 33 trolamine water carbomer homopolymer, unspecified type pigment violet 23 pigment green 7

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-09-24

Description

●store between 15- 40°C (59-104°F) ●Avoid freezing and excessive heat above 40°C(104°F)

Medication Information

Warnings and Precautions

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

Active Ingredient

ALCOHOL

Indications and Usage

Place enough product on hands to cover all surfaces.Rub hands together until dry.

Dosage and Administration

●store between 15- 40°C (59-104°F)

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

Description

●store between 15- 40°C (59-104°F) ●Avoid freezing and excessive heat above 40°C(104°F)

Section 50565-1

keep out of reach of children,If swallowed,get medicalhelp or contact a poison control center right away.

Section 51727-6

WATER,CARBOMER,TRIETHANOLAMINE,CI 17200,CI 51319,CI 42090,CI 74260

Section 51945-4

Section 55105-1

Disinfe ction

Sterilization

No Rinseing

Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

ALCOHOL

Indications and Usage (34067-9)

Place enough product on hands to cover all surfaces.Rub hands together until dry.

Dosage and Administration (34068-7)

●store between 15- 40°C (59-104°F)

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

Section 50565-1 (50565-1)

keep out of reach of children,If swallowed,get medicalhelp or contact a poison control center right away.

Section 51727-6 (51727-6)

WATER,CARBOMER,TRIETHANOLAMINE,CI 17200,CI 51319,CI 42090,CI 74260

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfe ction

Sterilization

No Rinseing

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "22.5", "strengthDenominator": "30", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PIGMENT VIOLET 23", "unii": "8U8Z6628KF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PIGMENT GREEN 7", "unii": "BPO9294G4W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Place enough product on hands to cover all surfaces.Rub hands together until dry.", "34068-7": "●store between 15- 40°C (59-104°F) ●Avoid freezing and excessive heat above 40°C(104°F)", "34071-1": "For external use only. Flammable.Keep away from heat or flame.", "50565-1": "keep out of reach of children,If swallowed,get medicalhelp or contact a poison control center right away.", "51727-6": "WATER,CARBOMER,TRIETHANOLAMINE,CI 17200,CI 51319,CI 42090,CI 74260", "55105-1": "Disinfe ction Sterilization No Rinseing", "55106-9": "ALCOHOL"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:48.073800 · Updated: 2026-03-14T22:58:31.850591