af8f7588-93f8-491d-8c2b-6ef31c199027

SPL v2
SPL
SPL Set ID af8f7588-93f8-491d-8c2b-6ef31c199027
Route
topical
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (130 mg)
Inactive Ingredients
water methylchloroisothiazolinone glycerin methylisothiazolinone cetrimonium chloride caprylyl glycol propylene glycol phenoxyethanol decyl glucoside coco glucoside glyceryl oleate behentrimonium chloride peg-7 glyceryl cocoate polysorbate 20 aloe vera leaf betaine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-12

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Uses

Hand Sanitizer to help reduce bacteria on skin.

Purpose

Antibacterial

Directions

Pull out one sheet from the pack. Clean hands or affected area.

Discard wipes in trash receptacle after use.

Do not flush.

Close lid after each used to keep wipes fresh.

Other Information

• Store below 104°F (40°C)

Inactive Ingredients

Aqua, Coco Glucoside, Caprylyl Glycol, Cetrimonium Chloride, Behetrimonium Chloride, Decyl Glucoside, Peg-7 Glyceril Cocoate, Glyceril Oleate, Glycerin, Phenoxyethanol, Methylisothiozolinone, Methylchloro Isothiozolinone, Betain, Aloevera Leaf, Polysorbate 20 , Propylene glycol.

Description

Benzalkonium chloride 0.13%

Drug Facts

Product Label

Active Ingredient

Benzalkonium chloride 0.13%

Keep Out of Reach of Children

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Uses

Hand Sanitizer to help reduce bacteria on skin.

Purpose

Antibacterial

Directions

Pull out one sheet from the pack. Clean hands or affected area.

Discard wipes in trash receptacle after use.

Do not flush.

Close lid after each used to keep wipes fresh.

Other Information (Other information)

• Store below 104°F (40°C)

Inactive Ingredients (Inactive ingredients)

Aqua, Coco Glucoside, Caprylyl Glycol, Cetrimonium Chloride, Behetrimonium Chloride, Decyl Glucoside, Peg-7 Glyceril Cocoate, Glyceril Oleate, Glycerin, Phenoxyethanol, Methylisothiozolinone, Methylchloro Isothiozolinone, Betain, Aloevera Leaf, Polysorbate 20 , Propylene glycol.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Keep Out of Reach of Children (Keep out of reach of children)

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)