dial mountain fresh

SPL v8

SPL

SPL Set ID 568518c8-e327-45a7-e054-00144ff8d46c

Route

topical

Published

Effective Date 2023-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.1 g)

Inactive Ingredients

glycerin water alcohol sodium palm kernelate tetrasodium glutamate diacetate fd&c green no. 3 basic yellow 57 stearic acid sodium palmate titanium dioxide sorbitol sodium chloride

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2017-07-01 Until 2024-12-04

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.1%

Medication Information

Uses

For washing to decrease the bacteria on the skin.

Purpose

Antibacterial

Directions

wet bar with water

lather vigorously and wash skin

rinse and dry thoroughly

Description

Benzalkonium Chloride 0.1%

Section 51945-4

Warning

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop using and ask doctor if irritation or redness develops.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredient

Sodium Palmate

Water

Sodium Palm Kernelate

Sodium Palmate

Sodium Cocoate

Glycerin

Stearic Acid

Palm Acid

Palm Kernel Acid

Coconut Acid

Fragrance

CI 77891 (Titanium Dioxide)

Sodium Chloride

Sorbitol

Tetrasodium Glutamate Diacetate

Alcohol

CI 19140 (Yellow 5)

CI 42053 (Green 3)

CONTAINS ONE OR MORE OF THESE INGREDIENTS

Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away.

Structured Label Content

Uses

For washing to decrease the bacteria on the skin.

Purpose

Antibacterial

Directions

wet bar with water

lather vigorously and wash skin

rinse and dry thoroughly

Section 51945-4 (51945-4)

Warning

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop using and ask doctor if irritation or redness develops.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredient

Sodium Palmate

Water

Sodium Palm Kernelate

Sodium Palmate

Sodium Cocoate

Glycerin

Stearic Acid

Palm Acid

Palm Kernel Acid

Coconut Acid

Fragrance

CI 77891 (Titanium Dioxide)

Sodium Chloride

Sorbitol

Tetrasodium Glutamate Diacetate

Alcohol

CI 19140 (Yellow 5)

CI 42053 (Green 3)

CONTAINS ONE OR MORE OF THESE INGREDIENTS

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

If swallowed, get medical help or contact Poison Control Center right away.

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "13.88", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM PALM KERNELATE", "unii": "6H91L1NXTW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRASODIUM GLUTAMATE DIACETATE", "unii": "5EHL50I4MY", "classCode": "IACT", "strengthNumerator": "0.058", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "0.001", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BASIC YELLOW 57", "unii": "4N63359G0X", "classCode": "IACT", "strengthNumerator": "0.0063", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "2.42", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM PALMATE", "unii": "S0A6004K3Z", "classCode": "IACT", "strengthNumerator": "61.85", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "0.388", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For washing to decrease the bacteria on the skin.", "Purpose": "Antibacterial", "Warning": "For external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop using and ask doctor if irritation or redness develops.", "Directions": "wet bar with water lather vigorously and wash skin rinse and dry thoroughly", "Active Ingredient": "Benzalkonium Chloride 0.1%", "Inactive Ingredient": "Sodium Palmate Water Sodium Palm Kernelate Sodium Palmate Sodium Cocoate Glycerin Stearic Acid Palm Acid Palm Kernel Acid Coconut Acid Fragrance CI 77891 (Titanium Dioxide) Sodium Chloride Sorbitol Tetrasodium Glutamate Diacetate Alcohol CI 19140 (Yellow 5) CI 42053 (Green 3) CONTAINS ONE OR MORE OF THESE INGREDIENTS", "Keep out of reach of children": "If swallowed, get medical help or contact Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:13.106759 · Updated: 2026-03-14T23:10:28.026216