199a96c1-94b8-3de6-e063-6394a90ab478

SPL v1

SPL

SPL Set ID 199a96c1-94b8-3de6-e063-6394a90ab478

Route

topical

Published

Effective Date 2024-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

salicylic acid (1 mg)

Inactive Ingredients

ethylhexylglycerin tert-butyl alcohol phenoxyethanol sodium polyacrylate (2500000 mw) xanthan gum water niacinamide medium-chain triglycerides ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) allantoin zinc pidolate sorbitan isostearate glycerin hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%)

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-06-01

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 60559-2

Structured Label Content

Warnings and Precautions (34071-1)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 60559-2 (60559-2)

Advanced Ingredient Data

[{"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "TERT-BUTYL ALCOHOL", "unii": "MD83SFE959", "classCode": "IACT", "strengthNumerator": "0.042", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "9", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SODIUM POLYACRYLATE (2500000 MW)", "unii": "05I15JNI2J", "classCode": "IACT", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "8.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "766.2865", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "84.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)", "unii": "Q7UI015FF9", "classCode": "IACT", "strengthNumerator": "1.995", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ZINC PIDOLATE", "unii": "C32PQ86DH4", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITAN ISOSTEARATE", "unii": "01S2G2C1E4", "classCode": "IACT", "strengthNumerator": "0.814", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "63.1825", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)", "unii": "86FQE96TZ4", "classCode": "IACT", "strengthNumerator": "12.58", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:07.811584 · Updated: 2026-03-14T23:03:01.087200