51706-907 Sanitizing Wipes 0.13% Benzalkonium Chloride

51706-907 Sanitizing Wipes 0.13% Benzalkonium Chloride
SPL v1
SPL
SPL Set ID a6ea6e80-fe39-18d7-e053-2a95a90a8476
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Triethoxy(3-isocyanatopropyl)silane Phenoxyethanol Citric Acid Monohydrate Water Caprylyl Glucoside Laureth-4 Polihexanide Aloe Vera Leaf Trimethyl Octadecyl Ammonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-27

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic/Hand & Skin Sanitizer


Medication Information

Purpose

Antiseptic/Hand & Skin Sanitizer

Description

Benzalkonium Chloride 0.13%

Use

Sanitizing Hand Wipes to help decrease bacteria on the skin.

Recommended for single use.

Section 50565-1

Keep out of reach of children.

Warnings

Do not freeze. For external use only.

Do not use in ears, eyes or mouth.

●Avoid contact with the eyes. In case of contact, flush eyes with water.

●Stop use and ask a doctor if redness or iritation

develop and persist for more than 72 hours.

●Keep out of reach of children.

●Children should be supervised when using this product.

Directions

Wipe liberally over the hands & body, rub into skin until dry.

Recommended for single use.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aloe Barbadensis leaf extract, Aqua, Citric Acid, CaprylyI Glucoside,

Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl

Steardimonium Chloride.

Package Label Principal Display Panel


Structured Label Content

Use

Sanitizing Hand Wipes to help decrease bacteria on the skin.

Recommended for single use.

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antiseptic/Hand & Skin Sanitizer

Warnings

Do not freeze. For external use only.

Do not use in ears, eyes or mouth.

●Avoid contact with the eyes. In case of contact, flush eyes with water.

●Stop use and ask a doctor if redness or iritation

develop and persist for more than 72 hours.

●Keep out of reach of children.

●Children should be supervised when using this product.

Directions

Wipe liberally over the hands & body, rub into skin until dry.

Recommended for single use.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis leaf extract, Aqua, Citric Acid, CaprylyI Glucoside,

Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl

Steardimonium Chloride.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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