Enriched Foam Alcohol-free Hand Sanitizer

Enriched Foam Alcohol-free Hand Sanitizer
SPL v6
SPL
SPL Set ID 0a6456aa-69f7-476b-afbb-3dd69377e8b2
Route
TOPICAL
Published
Effective Date 2021-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (13 mg)
Inactive Ingredients
Water Propylene Glycol Caprylocaproyl Polyoxylglycerides 6 Phenoxyethanol Decylamine Oxide Tetrasodium Glutamate Diacetate Sodium Hydroxide Caprylyl Glycol Ethylhexylglycerin Lactic Acid, Unspecified Form Sodium Chloride Hexylene Glycol Benzoic Acid .alpha.-tocopherol, D- Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-06-21 Until 2023-04-08

Description

Drug Facts

Purpose

Antiseptic Cleaner


Medication Information

Purpose

Antiseptic Cleaner

Description

Drug Facts

Use

To decrease potentially harmful germs on skin.

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor, if irritation or redness persist.
Section 50567-7
  • When using this product avoid contact with eyes. In case of eye contact, flush with water.
Section 50570-1
  • Do not ingest.
Warnings
  • For external use only.
Directions

Place hands under the dispenser, allow 0.4 mL of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry

Questions?

1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

Active Ingredient

0.13% Benzalkonium Chloride

Inactive Ingredients

Water (Aqua), Propylene Glycol, PEG-6 Caprylic/Capric Glycerides, Phenoxyethanol, Decylamine Oxide, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Lactic Acid, Shea Butteramidopropyl Betaine, Sodium Chloride, Hexylene Glycol, Benzoic Acid, Tocopherol, Sodium Citrate

Principal Display Panel 1100 Ml Pouch Label

Rubbermaid®

Commercial Products

Enriched Foam Alcohol-Free Hand Sanitizer

With Shea Butter & Vitamin E

NSF®

Nonfood Compounds

Program Listed E3

NSF Registration #143589

1100 mL (37.2 FL. OZ. U.S.)

© 2021 | 2147031 | PRFR11080 FRONT

PRFR11080 V-06-2021 FRONT


Structured Label Content

Use

To decrease potentially harmful germs on skin.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor, if irritation or redness persist.
Section 50567-7 (50567-7)
  • When using this product avoid contact with eyes. In case of eye contact, flush with water.
Section 50570-1 (50570-1)
  • Do not ingest.
Purpose

Antiseptic Cleaner

Warnings
  • For external use only.
Directions

Place hands under the dispenser, allow 0.4 mL of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry

Questions?

1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

Active Ingredient

0.13% Benzalkonium Chloride

Inactive Ingredients

Water (Aqua), Propylene Glycol, PEG-6 Caprylic/Capric Glycerides, Phenoxyethanol, Decylamine Oxide, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Lactic Acid, Shea Butteramidopropyl Betaine, Sodium Chloride, Hexylene Glycol, Benzoic Acid, Tocopherol, Sodium Citrate

Principal Display Panel 1100 Ml Pouch Label (PRINCIPAL DISPLAY PANEL - 1100 mL Pouch Label)

Rubbermaid®

Commercial Products

Enriched Foam Alcohol-Free Hand Sanitizer

With Shea Butter & Vitamin E

NSF®

Nonfood Compounds

Program Listed E3

NSF Registration #143589

1100 mL (37.2 FL. OZ. U.S.)

© 2021 | 2147031 | PRFR11080 FRONT

PRFR11080 V-06-2021 FRONT


Advanced Ingredient Data


Raw Label Data

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