75127-003 University Medical Pharmaceuticals Antibacterial Hand Wipes 0.13% Benzalkonium Chloride

75127-003 University Medical Pharmaceuticals Antibacterial Hand Wipes 0.13% Benzalkonium Chloride
SPL v2
SPL
SPL Set ID ae4c6f43-6ead-0e7d-e053-2995a90a8ba7
Route
TOPICAL
Published
Effective Date 2020-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Iodopropynyl Butylcarbamate Methylisothiazolinone Polysorbate 20 Lanolin Aloe Vera Leaf Allantoin Vitamin A Palmitate Edetate Disodium Anhydrous Glycerin Isopropyl Myristate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-02

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

hand sanitizer to help reduce bacteria on the skin.

Section 50565-1

●Keep out of reach of children unless under adult supervision.

Section 51945-4

Warning

For external use only.

Do not use In or near the eyes In case of eye

contact ,rinse eyes thoroughly with water.

Stop use and ask a doctor If Irritation or rash

develops and persists more than 72 hours.

Directions

Wet hands thoroughly with wipe(s) and

allow to air dry.

Discard after single use in trash bin. Do not

flush.

To dispense peel back front label at tab

enough to remove wipe(s)Press label firmly

back In place to reseal pouch.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aqua, Glycerol, Aloe Barbadensis Leaf Juice,

lanolin, Retinyl Palmitate, Allantoin,

Polysorbate-20, Disodium EDTA, lodopropynyl

Butylcarbamate , Methylisothlazollnone ,

lsopropyl Myristate.


Structured Label Content

Use (USE)

hand sanitizer to help reduce bacteria on the skin.

Section 50565-1 (50565-1)

●Keep out of reach of children unless under adult supervision.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warning

For external use only.

Do not use In or near the eyes In case of eye

contact ,rinse eyes thoroughly with water.

Stop use and ask a doctor If Irritation or rash

develops and persists more than 72 hours.

Directions

Wet hands thoroughly with wipe(s) and

allow to air dry.

Discard after single use in trash bin. Do not

flush.

To dispense peel back front label at tab

enough to remove wipe(s)Press label firmly

back In place to reseal pouch.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerol, Aloe Barbadensis Leaf Juice,

lanolin, Retinyl Palmitate, Allantoin,

Polysorbate-20, Disodium EDTA, lodopropynyl

Butylcarbamate , Methylisothlazollnone ,

lsopropyl Myristate.


Advanced Ingredient Data


Raw Label Data

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