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SPL v1

SPL

SPL Set ID a5e87486-f81d-49ed-8bf7-a96efd3fe910

Route

TOPICAL

Published

Effective Date 2015-10-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (.13 mg) .alpha.-tocopherol, Dl- (1 mg)

Inactive Ingredients

Aloe Vera Leaf Citric Acid Acetate Glycerin Hamamelis Virginiana Root Bark/stem Bark Phenoxyethanol Polysorbate 20 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-10-02

Description

Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water

Warnings

For External Use Only

When using this product avoid contact with eyes,

Stop use and ask a doctor

if irritation or redness develop
if conditions persists for more than 72 hours

Directions

To open or close package see illustrations on the left
remove wipe
wipe hands thoroughly for 30 seconds
discard in trash, do not flush

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water

Principal Display Panel

Keep Out of Reach of Children

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

Structured Label Content

Purpose

Antimicrobial

Warnings

For External Use Only

When using this product avoid contact with eyes,

Stop use and ask a doctor

if irritation or redness develop
if conditions persists for more than 72 hours

Directions

To open or close package see illustrations on the left
remove wipe
wipe hands thoroughly for 30 seconds
discard in trash, do not flush

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water

Principal Display Panel

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

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

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": ".13", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID ACETATE", "unii": "DSO12WL7AU", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK", "unii": "T7S323PKJS", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL, DL-", "unii": "7QWA1RIO01", "classCode": "ACTIM", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Purpose": "Antimicrobial", "Warnings": "For External Use Only When using this product avoid contact with eyes, Stop use and ask a doctor if irritation or redness develop if conditions persists for more than 72 hours", "Directions": "To open or close package see illustrations on the left remove wipe wipe hands thoroughly for 30 seconds discard in trash, do not flush", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water", "Keep out of reach of children": "If swallowed, get medical help or contact Poision Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:00.304835 · Updated: 2026-03-14T22:54:08.799167