11822-0286 Simplify Antibacterial Hand Wipes

11822-0286 Simplify Antibacterial Hand Wipes
SPL v3
SPL
SPL Set ID 20a55634-fb0a-8058-e063-6294a90ac067
Route
TOPICAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Caprylyl Glycol Dihydroxypropyl Peg-5 Linoleammonium Chloride Citric Acid Monohydrate Potassium Sorbate Water Aloe Vera Leaf Phenoxyethanol Alcohol Peg-8 Dimethicone Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredient Benzalkonium chloride 0.13%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses · to decrease bacteria on the skin

· recommended for repeated use

Dosage and Administration

Directions

· rub wipe thoroughly over all surfaces of both hands

· allow to dry without wiping

· supervise children under 6 years old

· not recommended for infants

· dispose of wipe in trash; do not flush

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 immediately.

Section 50566-9

Stop use and ask a doctor if irritation or redness

develop or last more than 72 hours.

Section 50567-7

When using this product keep away from eyes.

In case of eye contact, rinses eyes with water.

Section 51727-6

Inactive ingredients

Water, Alcohol Denat., Phenoxyethanol, PEG-8 Dimethicone, Caprylyl Glycol, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Potassium Sorbate, Disodium EDTA, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice

Section 51945-4

1 Wipe

5.0 IN × 7.8 IN

(12.7 cm × 19.8 cm)

NDC: 11822-0286-1



24 Wipes

Individually Wrapped

5.0 IN × 7.8 IN

(12.7 cm × 19.8 cm)

NDC: 11822-0286-2

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses · to decrease bacteria on the skin

· recommended for repeated use

Dosage and Administration (34068-7)

Directions

· rub wipe thoroughly over all surfaces of both hands

· allow to dry without wiping

· supervise children under 6 years old

· not recommended for infants

· dispose of wipe in trash; do not flush

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 immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness

develop or last more than 72 hours.

Section 50567-7 (50567-7)

When using this product keep away from eyes.

In case of eye contact, rinses eyes with water.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Alcohol Denat., Phenoxyethanol, PEG-8 Dimethicone, Caprylyl Glycol, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Potassium Sorbate, Disodium EDTA, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice

Section 51945-4 (51945-4)

1 Wipe

5.0 IN × 7.8 IN

(12.7 cm × 19.8 cm)

NDC: 11822-0286-1



24 Wipes

Individually Wrapped

5.0 IN × 7.8 IN

(12.7 cm × 19.8 cm)

NDC: 11822-0286-2

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium chloride 0.13%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)