1438 dynarex antibacterial hand soap ndc 67777-318-01

SPL v6

SPL

SPL Set ID 59b098d2-08de-4fdb-a209-ae226abf37d6

Route

topical

Published

Effective Date 2017-06-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

chloroxylenol (0.15 g)

Inactive Ingredients

anhydrous citric acid cocamidopropyl betaine coco diethanolamide edetate disodium glycerin sodium laureth sulfate sodium chloride water sodium o-phenylphenate d&c red no. 33

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2017-03-13

Purpose

An antiseptic handwash.

Description

Active Ingredient Purpose Chloroxylenol 0.15% Antiseptic

Medication Information

Warnings

For external use only
When using this product avoid contact with eyes. In case of contact, flush with water.

Purpose

An antiseptic handwash.

Inactive Ingredients

Inactive ingredients: Citric acid, Cocamidopropyl betaine, Cocmide DEA, D&C Red #33, Disodium EDTA, Frgarance, Glycerin, Sodium chloride, Sodium Lauryl Sulphate, Sodium o-phenylphenate, water.

Description

Active Ingredient Purpose Chloroxylenol 0.15% Antiseptic

Principal Display Panel

Dynarex Antibacterial Soap

1438 Soap.jpg

Active Ingredient

Active Ingredient Purpose

Chloroxylenol 0.15% Antiseptic

Indications & Usage

Cleaning and antiseptic cleansing of hands and skin.

Dosage & Administration

Wet hands and forearms. Apply 5 milliliters (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 1 minute. Rinse and repeat.

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation and redness develop.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN, if swallowed get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings (WARNINGS)

For external use only
When using this product avoid contact with eyes. In case of contact, flush with water.

Purpose (PURPOSE)

An antiseptic handwash.

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients: Citric acid, Cocamidopropyl betaine, Cocmide DEA, D&C Red #33, Disodium EDTA, Frgarance, Glycerin, Sodium chloride, Sodium Lauryl Sulphate, Sodium o-phenylphenate, water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dynarex Antibacterial Soap

1438 Soap.jpg

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient Purpose

Chloroxylenol 0.15% Antiseptic

Indications & Usage (INDICATIONS & USAGE)

Cleaning and antiseptic cleansing of hands and skin.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Wet hands and forearms. Apply 5 milliliters (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 1 minute. Rinse and repeat.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if irritation and redness develop.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN, if swallowed get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCO DIETHANOLAMIDE", "unii": "92005F972D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM O-PHENYLPHENATE", "unii": "KFV9K7N7UI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROXYLENOL", "unii": "0F32U78V2Q", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "An antiseptic handwash.", "WARNINGS": "For external use only When using this product avoid contact with eyes. In case of contact, flush with water.", "ACTIVE INGREDIENT": "Active Ingredient Purpose Chloroxylenol 0.15% Antiseptic", "INDICATIONS & USAGE": "Cleaning and antiseptic cleansing of hands and skin.", "INACTIVE INGREDIENTS": "Inactive ingredients: Citric acid, Cocamidopropyl betaine, Cocmide DEA, D&C Red #33, Disodium EDTA, Frgarance, Glycerin, Sodium chloride, Sodium Lauryl Sulphate, Sodium o-phenylphenate, water.", "DOSAGE & ADMINISTRATION": "Wet hands and forearms. Apply 5 milliliters (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 1 minute. Rinse and repeat.", "PRINCIPAL DISPLAY PANEL": "Dynarex Antibacterial Soap 1438 Soap.jpg", "Stop use and ask a doctor if": "Stop use and ask a doctor if irritation and redness develop.", "KEEP OUT OF REACH OF CHILDREN": "KEEP OUT OF REACH OF CHILDREN, if swallowed get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:29.238045 · Updated: 2026-03-14T23:05:15.511736