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NDC 69243-1110-01 Germ Bloc Disinfecting Hand Wipes 0.0013 g/mL Details

Germ Bloc Disinfecting Hand Wipes 0.0013 g/mL

Germ Bloc Disinfecting Hand Wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Willspeed Technologies LLC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	69243-1110
Product ID	69243-1110_37a35d53-e2ed-4657-95dc-629adfcb87fe
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Germ Bloc Disinfecting Hand Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.0013
Active Ingredient Units	g/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Willspeed Technologies LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69243-1110-01 (69243111001)

Pricing Information	N/A
NDC Package Code	69243-1110-1
Billing NDC	69243111001
Package	295.7 mL in 1 CONTAINER (69243-1110-1)
Marketing Start Date	2020-11-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5ce1d14c-137f-4ccf-b80a-6e72d417001c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do not use

in the eyes.

In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

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

Keep out of reach of children.

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and over

- apply to hands

- allow to dry without wiping

Children under the age of 2

- ask doctor before use

Inactive Ingredients

Aloe Barbadensis Extract, Avena Sativa (Oat) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylol Glycol, Citrus Grandis (Grapefruit) Seed Extract, Cocamidopropyl Betaine, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Thymus Vulgaris (Thyme) Extract, Vitamin E Acetate, Water.

PRINCIPAL DISPLAY PANEL

Alcohol-Free Formula

GERM BLOCTM

Kills 99.9% of Germs

Disinfecting Hand Wipes

80 Count

Hypoallergenic Paraben Free

Keep Out Of Reach Of Children

16.7oz (1LB 0.7oz) 473g

INGREDIENTS AND APPEARANCE

GERM BLOC DISINFECTING HAND WIPES

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69243-1110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENA SATIVA LEAF (UNII: 206PI19V7R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRUS MAXIMA SEED (UNII: 083X55C543)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
THYME (UNII: CW657OBU4N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69243-1110-1	295.7 mL in 1 CONTAINER; Type 0: Not a Combination Product	11/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/06/2020

Labeler - Willspeed Technologies LLC (019063540)

Revised: 1/2022

Document Id: 37a35d53-e2ed-4657-95dc-629adfcb87fe

Set id: 5ce1d14c-137f-4ccf-b80a-6e72d417001c

Version: 2

Effective Time: 20220114