448adc0d-6431-b0ab-e063-6294a90a842e

SPL v1

SPL

SPL Set ID 448adc0d-6431-b0ab-e063-6294a90a842e

Route

cutaneous

Published

Effective Date 2025-11-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

valeric acid (20 g)

Inactive Ingredients

sodium chloride benzethonium chloride fragrance 13576 sodium hydroxide calcium carbonate water glycerin tetrasodium edta etidronate tetrasodium

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-11-27

Description

Calcium Carbonate Water Glycerin Sodium Chloride Sodium Hydroxide Fragrance Etidronate Tetrasodium Tetrasodium EDTA Benzethonium Chloride

Medication Information

Warnings and Precautions

For ecternal use only.

Active Ingredient

Product 1：

Sodium Palmate 21.6%

Sodium Palm Kernelate 20%

Sodium Cocoate 7.05%

Product 2：

Sodium Palmate 21.5%

Sodium Palm Kernelate 20%

Sodium Cocoate 7.05%

Indications and Usage

USES:To decrease boeteriaon the skin that could causedisease.

Dosage and Administration

INSIRUCTIONS:Wet hands tharoughly with produet and allow to dry without wiping

Description

Calcium Carbonate Water Glycerin Sodium Chloride Sodium Hydroxide Fragrance Etidronate Tetrasodium Tetrasodium EDTA Benzethonium Chloride

Section 50565-1

Keep out of eyes: In case of contact with eyes,please fush thoroughly with water.

Section 51727-6

Calcium Carbonate

Water

Glycerin

Sodium Chloride

Sodium Hydroxide

Fragrance

Etidronate Tetrasodium

Tetrasodium EDTA

Benzethonium Chloride

Section 51945-4

Section 55105-1

Sterilization

Structured Label Content

Warnings and Precautions (34071-1)

For ecternal use only.

Active Ingredient (55106-9)

Product 1：

Sodium Palmate 21.6%

Sodium Palm Kernelate 20%

Sodium Cocoate 7.05%

Product 2：

Sodium Palmate 21.5%

Sodium Palm Kernelate 20%

Sodium Cocoate 7.05%

Indications and Usage (34067-9)

USES:To decrease boeteriaon the skin that could causedisease.

Dosage and Administration (34068-7)

INSIRUCTIONS:Wet hands tharoughly with produet and allow to dry without wiping

Section 50565-1 (50565-1)

Keep out of eyes: In case of contact with eyes,please fush thoroughly with water.

Section 51727-6 (51727-6)

Calcium Carbonate

Water

Glycerin

Sodium Chloride

Sodium Hydroxide

Fragrance

Etidronate Tetrasodium

Tetrasodium EDTA

Benzethonium Chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sterilization

Advanced Ingredient Data

[{"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BENZETHONIUM CHLORIDE", "unii": "PH41D05744", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "6.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "21.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "7.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TETRASODIUM EDTA", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "0.6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ETIDRONATE TETRASODIUM", "unii": "CZZ9T1T1X4", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "21.6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TETRASODIUM EDTA", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "0.6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "7.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "6.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ETIDRONATE TETRASODIUM", "unii": "CZZ9T1T1X4", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BENZETHONIUM CHLORIDE", "unii": "PH41D05744", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USES:To decrease boeteriaon the skin that could causedisease.", "34068-7": "INSIRUCTIONS:Wet hands tharoughly with produet and allow to dry without wiping", "34071-1": "For ecternal use only.", "50565-1": "Keep out of eyes: In case of contact with eyes,please fush thoroughly with water.", "51727-6": "Calcium Carbonate Water Glycerin Sodium Chloride Sodium Hydroxide Fragrance Etidronate Tetrasodium Tetrasodium EDTA Benzethonium Chloride", "55105-1": "Sterilization", "55106-9": "Product 1： Sodium Palmate 21.6% Sodium Palm Kernelate 20% Sodium Cocoate 7.05% Product 2： Sodium Palmate 21.5% Sodium Palm Kernelate 20% Sodium Cocoate 7.05%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:25.137554 · Updated: 2026-03-14T23:10:50.302579