SPL v1
SPL
SPL Set ID b443fe7a-4786-29f7-e053-2995a90a5e26
Route
TOPICAL
Published
Effective Date 2020-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Aloe Vera Leaf .alpha.-tocopherol Acetate Phenoxyethanol Polysorbate 20 Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-17
Description

To decrease bacteria on the skin that could cause disease 1.Remove the wipe from the center of the canister. 2.The next wipe will come out automatically. 3.Close the lid to keep the wipes moist.

Medication Information

Warnings and Precautions

For external use only

Description

To decrease bacteria on the skin that could cause disease 1.Remove the wipe from the center of the canister. 2.The next wipe will come out automatically. 3.Close the lid to keep the wipes moist.

Uses

To decrease bacteria on the skin that could cause disease

1.Remove the wipe from the center of the canister.

2.The next wipe will come out automatically.

3.Close the lid to keep the wipes moist.

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help orcontact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness developcondition persists for more than 72 hours.

Section 50567-7

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skin

Section 51727-6

aloe barbadensis leaf juice, fragrance, phenoxyethanol,polysorbate 20, propylene glycol, tocopheryl acetate, water

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Benzalkonium Chloride 0.13%

Directions

allow to dry without wiping for children under 6, use only underadult supervision not recommended for infants

Other Information

keep containers tightly closed in a dry, cool and well-ventilated place

recommended storage temperature: 32°F to 104°F(0°C to 40°c)

Structured Label Content

Uses

To decrease bacteria on the skin that could cause disease

1.Remove the wipe from the center of the canister.

2.The next wipe will come out automatically.

3.Close the lid to keep the wipes moist.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help orcontact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness developcondition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skin

Section 51727-6 (51727-6)

aloe barbadensis leaf juice, fragrance, phenoxyethanol,polysorbate 20, propylene glycol, tocopheryl acetate, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%

Directions

allow to dry without wiping for children under 6, use only underadult supervision not recommended for infants

Other Information (Other information)

keep containers tightly closed in a dry, cool and well-ventilated place

recommended storage temperature: 32°F to 104°F(0°C to 40°c)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:03.272429 · Updated: 2026-03-14T22:58:52.562418