84323-007-01 Healthewipesmc

84323-007-01 Healthewipesmc
SPL v1
SPL
SPL Set ID 35671452-b82b-bf61-e063-6294a90a3b75
Route
TOPICAL
Published
Effective Date 2025-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Aqua Glycerin Phenoxyethanol Fragrance Lemon Orc2001060 Didecyldimonium Chloride Propylene Glycol Decyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-18

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings and Precautions

For external use only

May irritate eyes

Indications and Usage

Tear V notch located on top of the plastic bag.

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Place entire bag inside of center pull dispenser.

Thread the wipe through the opening on the dispenser.

Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Dosage and Administration

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Description

Benzalkonium chloride 0.13%

Section 50565-1

unless under adult supervision

Section 50567-7

For hand sanitizing to decrease bacteria on the skin.

Section 51727-6

Inactive Ingredients

Aqua, Benzalkonium Chloride, Didecyldimonium Chloride, PhenoxyethanolGlycerin, Propylene Glycol, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Fragrance.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Tear V notch located on top of the plastic bag.

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Place entire bag inside of center pull dispenser.

Thread the wipe through the opening on the dispenser.

Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Dosage and Administration (34068-7)

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Warnings and Precautions (34071-1)

For external use only

May irritate eyes

Section 50565-1 (50565-1)

unless under adult supervision

Section 50567-7 (50567-7)

For hand sanitizing to decrease bacteria on the skin.

Section 51727-6 (51727-6)

Inactive Ingredients

Aqua, Benzalkonium Chloride, Didecyldimonium Chloride, PhenoxyethanolGlycerin, Propylene Glycol, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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