Simple Hygiene Alcohol Free Foam Hand Sanitizer

Simple Hygiene Alcohol Free Foam Hand Sanitizer
SPL v3
SPL
SPL Set ID b6fdf78f-4b9b-aca7-e053-2995a90a991c
Route
TOPICAL
Published
Effective Date 2020-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Undeceth-7 Water Lauramine Oxide Edetate Disodium Anhydrous Dmdm Hydantoin Citric Acid Monohydrate D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.1%

Uses

• For hand sanitizing to decrease bacteria on the skin.

• Recommended for repeated use.

Warnings

For external use only.

Directions

• Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands • Rub hands briskly together until dry.

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients:

Water; Lauramine Oxide; Undeceth-7; DisodiumEDTA; DMDM Hydantoin; Fragrance; Citric Acid; FD&C Red #33; FD&C Blue #1.

Package Labeling:1 Gal

Package Labeling:237ml

When Using This Product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor If

irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package Labeling:1 Gal 4 Bottles

Package Labeling: 237ml 24 Bottles


Structured Label Content

Uses

• For hand sanitizing to decrease bacteria on the skin.

• Recommended for repeated use.

Purpose

Antimicrobial

Warnings

For external use only.

Directions

• Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands • Rub hands briskly together until dry.

Drug Facts

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Inactive Ingredients:

Water; Lauramine Oxide; Undeceth-7; DisodiumEDTA; DMDM Hydantoin; Fragrance; Citric Acid; FD&C Red #33; FD&C Blue #1.

Package Labeling:1 Gal (Package Labeling:1 gal)

Package Labeling:237ml

When Using This Product (When using this product)

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or redness develops, or if condition persists for more than 72 hours.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Package Labeling:1 Gal 4 Bottles (Package Labeling:1 gal 4 bottles)

Package Labeling: 237ml 24 Bottles (Package Labeling: 237ml 24 bottles)


Advanced Ingredient Data


Raw Label Data

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