SPL v1
SPL
SPL Set ID b1210cb7-88f1-2301-e053-2995a90a90d0
Route
TOPICAL
Published
Effective Date 2020-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-08
Description

Benzalkonium Chloride

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Thoroughly wipe hands with wipe.

Discard properly. Not flushable.

Be sure to close lid to keep wipes moist.

Dosage and Administration

for external use only

Description

Benzalkonium Chloride

Section 50565-1

keep out of reach of the children

Section 51727-6

Propylene Glycol

Phenoxyethanol

Glycerin

Sodium Benzoate

Sodium Citrate

Disodium EDTA

Polysorbate 20

Citric Acid

Melaleuca Alternifolia (Tea Tree) Leaf Oil

Tocopheryl Acetate

Section 51945-4

Section 55105-1

Antibacterial Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 55106-9

Benzalkonium Chloride

Structured Label Content

Indications and Usage (34067-9)

Thoroughly wipe hands with wipe.

Discard properly. Not flushable.

Be sure to close lid to keep wipes moist.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Propylene Glycol

Phenoxyethanol

Glycerin

Sodium Benzoate

Sodium Citrate

Disodium EDTA

Polysorbate 20

Citric Acid

Melaleuca Alternifolia (Tea Tree) Leaf Oil

Tocopheryl Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 55106-9 (55106-9)

Benzalkonium Chloride

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:51.596418 · Updated: 2026-03-14T22:58:39.544338