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SPL v4

SPL

SPL Set ID bfd4d3fa-7b25-5286-e053-2995a90a279e

Route

TOPICAL

Published

Effective Date 2020-04-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hypochlorous Acid (0.008 g)

Inactive Ingredients

Indican Sorbitol Maltitol Water Fennel Seed

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2021-04-01

Description

hypochlorous acid

Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product • Keep out of eyes • In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor ifirritation or redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications and Usage

Do not dilute.• Use at strength for maximum effectiveness.• For equipment or products that are difficult to spray, apply liquid to clean gauze or cotton swab.

Dosage and Administration

for external use only

Description

hypochlorous acid

Section 50565-1

keep out of reach of the children

Section 51727-6

Foeniculum vulgare seed extract, Indican, Maltitol, Sorbitol, Water

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

hypochlorous acid

Structured Label Content

Indications and Usage (34067-9)

Do not dilute.• Use at strength for maximum effectiveness.• For equipment or products that are difficult to spray, apply liquid to clean gauze or cotton swab.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product • Keep out of eyes • In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor ifirritation or redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Foeniculum vulgare seed extract, Indican, Maltitol, Sorbitol, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

hypochlorous acid

Advanced Ingredient Data

[{"name": "INDICAN", "unii": "N187WK1Y1J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPOCHLOROUS ACID", "unii": "712K4CDC10", "classCode": "ACTIB", "strengthNumerator": "0.008", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FENNEL SEED", "unii": "G3QC02NIE6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Do not dilute.• Use at strength for maximum effectiveness.• For equipment or products that are difficult to spray, apply liquid to clean gauze or cotton swab.", "34068-7": "for external use only", "34071-1": "Warnings For external use only. When using this product • Keep out of eyes • In case of contact with eyes, flush thoroughly with water. Stop use and ask a doctor ifirritation or redness develop and persist for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "50565-1": "keep out of reach of the children", "51727-6": "Foeniculum vulgare seed extract, Indican, Maltitol, Sorbitol, Water", "55105-1": "Antiseptic", "55106-9": "hypochlorous acid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:32.984641 · Updated: 2026-03-14T22:59:34.580570