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SPL v8

SPL

SPL Set ID f5610cd3-16ca-3ab4-e053-2995a90a9e82

Route

topical

Published

Effective Date 2020-05-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 mg)

Inactive Ingredients

aloe vera leaf tea tree oil chamomile water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-02-23

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Medication Information

Warnings

For external use only. Keep away from heat or flame

Purpose

Antiseptic

Directions

Open lid, gently pull back resealable label, remove, and apply to hands and skin.

No rinsing required. Discard after use.

Children under 6 years of age should be supervised when using this product.

Other Information

Avoid freezing and store below 110F (43C), away from direct sunlight.

May discolor certain fabrics or surfaces.

Inactive Ingredients

water, flushable non-woven fabric, tea tree extract, chamomile extract, aloe vera extract

Description

Benzalkonium chloride 0.13%

Use

For sanitizing and to help reduce bacteria on the skin. For use when soap and water are not available.

Section 50565-1

Keep children out of reach unless under adult supervision. If swallowed, get medical help or contact a poison control center right away

Do Not Use

in or near the eyes.
on open skin wounds or burns

Active Ingredient(s)

Benzalkonium chloride 0.13%

Package Label Principal Display Panel

40 PCS, NDC: 75622-655-40

Structured Label Content

Warnings

For external use only. Keep away from heat or flame

Purpose

Antiseptic

Directions

Open lid, gently pull back resealable label, remove, and apply to hands and skin.

No rinsing required. Discard after use.

Children under 6 years of age should be supervised when using this product.

Other Information (Other information)

Avoid freezing and store below 110F (43C), away from direct sunlight.

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

water, flushable non-woven fabric, tea tree extract, chamomile extract, aloe vera extract

Use

For sanitizing and to help reduce bacteria on the skin. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep children out of reach unless under adult supervision. If swallowed, get medical help or contact a poison control center right away

Do Not Use (Do not use)

in or near the eyes.
on open skin wounds or burns

Active Ingredient(s)

Benzalkonium chloride 0.13%

Package Label Principal Display Panel (Package Label - Principal Display Panel)

40 PCS, NDC: 75622-655-40

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For sanitizing and to help reduce bacteria on the skin. For use when soap and water are not available.", "50565-1": "Keep children out of reach unless under adult supervision. If swallowed, get medical help or contact a poison control center right away", "Purpose": "Antiseptic", "Warnings": "For external use only. Keep away from heat or flame", "Directions": "Open lid, gently pull back resealable label, remove, and apply to hands and skin. No rinsing required. Discard after use. Children under 6 years of age should be supervised when using this product.", "Do not use": "in or near the eyes. on open skin wounds or burns", "Other information": "Avoid freezing and store below 110F (43C), away from direct sunlight. May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Benzalkonium chloride 0.13%", "Inactive ingredients": "water, flushable non-woven fabric, tea tree extract, chamomile extract, aloe vera extract", "Package Label - Principal Display Panel": "40 PCS, NDC: 75622-655-40"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.900481 · Updated: 2026-03-14T23:06:27.679265