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SPL v2

SPL

SPL Set ID ab1dad35-ec80-6e13-e053-2a95a90adfc3

Route

TOPICAL

Published

Effective Date 2020-07-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Carbomer 940 Water Alpha-tocopherol Acetate Polyoxyl 40 Hydrogenated Castor Oil Isopentyldiol Coceth-7 Trolamine Ppg-1-peg-9 Lauryl Glycol Ether

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-29

Medication Information

Purpose

Use[s]

Warnings

Directions

Active Ingredient

Inactive Ingredients

Principal Display Panel

Keep Out of Reach of Children

Structured Label Content

Use[s] (USE[s])

Purpose

Warnings

Directions

Active Ingredient

Inactive Ingredients

Principal Display Panel (Principal display panel)

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

Advanced Ingredient Data

[{"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPENTYLDIOL", "unii": "19NOL5474Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCETH-7", "unii": "58Y261JLH5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PPG-1-PEG-9 LAURYL GLYCOL ETHER", "unii": "5R8J43K25L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:20.277269 · Updated: 2026-03-14T22:57:50.764620