Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 924afbb0-0d3a-4d62-abbd-7cc1f88ddd92
Route
TOPICAL
Published
Effective Date 2019-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 g)
Inactive Ingredients
Water Polihexanide Caprylyl Glucoside C12-15 Pareth-7 Dimethicone Cetrimonium Chloride Laurtrimonium Chloride Dihydroxyethyl Cocamine Oxide Glycereth-17 Cocoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-15

Description

Active ingredient Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Dosage and Administration

Directions

Pump a small amount of foam onto hands.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

Description

Active ingredient Benzalkonium Chloride 0.13%

Section 50565-1

Keep out of the 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 develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6

Inactive ingredients

Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric acid.

Section 51945-4

PROTECT 8

Hand

Sanitizer

Alcohol Free

Fragrance Free

Gentle on Skin

16.9 FL OZ (500mL)

container label2

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Dosage and Administration (34068-7)

Directions

Pump a small amount of foam onto hands.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of the 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 develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric acid.

Section 51945-4 (51945-4)

PROTECT 8

Hand

Sanitizer

Alcohol Free

Fragrance Free

Gentle on Skin

16.9 FL OZ (500mL)

container label2

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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