DailyMed - DailyMed Details

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.

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

Section 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%

Structured Label Content

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

Warnings and Precautions (34071-1)

For ecternal use only.

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

Section 55106-9 (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%

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

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