SPL v2
SPL
SPL Set ID 33dbe9e3-4335-ada1-e063-6294a90ad2f5
Route
TOPICAL
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (12 mg)
Inactive Ingredients
Centella Asiatica Lonicera Caprifolium Flowering Top Water Glycerol Formal Aloe Barbadensis Leaf Juice

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-01

Description

Active ingredient Purpose Benzalkonium chloride 0.12% Antimicrobial


Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

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

Dosage and Administration

Directions Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry your hands. Dispose of wipe. Do not flush.

Description

Active ingredient Purpose Benzalkonium chloride 0.12% Antimicrobial

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years age should be supervised when using this product.

Section 51727-6

Inactive ingredients Aloe Barbadensis Leaf Extract, Centella AsiaƟca Extract, Chlorhexidine Diacetate, Deionized Water, Ethylhexylglycerin, Glycerol, Lonicera Caprifolium Extract.

Section 51945-4

Drug Facts Active ingredient Purpose Benzalkonium chloride 0.12% Antimicrobial Uses Hand sanitizer to help reduce bacteria on skin Recommended for repeated use When using this product avoid contact with eyes. In case of contact, flush eyes with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years age should be supervised when using this product. Stop use and ask a doctor if irritation and/or rash occurs and persists for more than 72 hours. Warnings For external use only Directions Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry your hands. Dispose of wipe. Do not flush. Inactive ingredients Aloe Barbadensis Leaf Extract, Centella AsiaƟca Extract, Chlorhexidine Diacetate, Deionized Water, Ethylhexylglycerin, Glycerol, Lonicera Caprifolium Extract.

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient Purpose

Benzalkonium chloride 0.12% Antimicrobial


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry your hands. Dispose of wipe. Do not flush.

Warnings and Precautions (34071-1)

Warnings For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years age should be supervised when using this product.

Section 51727-6 (51727-6)

Inactive ingredients Aloe Barbadensis Leaf Extract, Centella AsiaƟca Extract, Chlorhexidine Diacetate, Deionized Water, Ethylhexylglycerin, Glycerol, Lonicera Caprifolium Extract.

Section 51945-4 (51945-4)

Drug Facts Active ingredient Purpose Benzalkonium chloride 0.12% Antimicrobial Uses Hand sanitizer to help reduce bacteria on skin Recommended for repeated use When using this product avoid contact with eyes. In case of contact, flush eyes with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years age should be supervised when using this product. Stop use and ask a doctor if irritation and/or rash occurs and persists for more than 72 hours. Warnings For external use only Directions Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry your hands. Dispose of wipe. Do not flush. Inactive ingredients Aloe Barbadensis Leaf Extract, Centella AsiaƟca Extract, Chlorhexidine Diacetate, Deionized Water, Ethylhexylglycerin, Glycerol, Lonicera Caprifolium Extract.

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredient Purpose

Benzalkonium chloride 0.12% Antimicrobial


Advanced Ingredient Data


Raw Label Data

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