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NDC 69243-0610-03 Germ Bloc Hand Sanitizer 0.0013 g/mL Details

Germ Bloc Hand Sanitizer 0.0013 g/mL

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

Product Information

NDC	69243-0610
Product ID	69243-0610_46dcde68-fcd6-4d94-8a6a-082ca39e07e6
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 Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
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 69243-0610-03 (69243061003)

Pricing Information	N/A
NDC Package Code	69243-0610-3
Billing NDC	69243061003
Package	89 mL in 1 BOTTLE, PUMP (69243-0610-3)
Marketing Start Date	2014-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5743e2d7-7721-4b9a-9b53-8c4700841460 Details

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Kills 99.99 % germs and moisturizes 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

Apply a small amount to hands every 3 to 4 hours and rub until dry. Does not replace soap and water.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Extract, Behentrimonium Methosulfate, Butylene Glycol, Caprylyl Glycol, Centrimonium Chloride, Dimethicone, Emulsifying Wax NF, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Retinyl Palmitate Vitamin A, Simmondsia Chinensis (Jojoba) Seed Oil, Sorbic Acid, Tetrasodium EDTA, Tocopheryl Acetate Vitamin E, Water

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Kills 99.99 % germs and moisturizes 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

Apply a small amount to hands every 3 to 4 hours and rub until dry. Does not replace soap and water.

Inactive Ingredients

Aloe Barbadensis Extract, Avena Sativa (Oat) Extract, Behentrimonium Methosulfate, Caprylyl Glycol, Cetearyl Alcohol, Cetrimonium Chloride, Dimethicone, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Vitamin A Palmitate, Vitamin E Acetate, Water.

PRINCIPAL DISPLAY PANEL

ALCOHOL-FREE

Kills 99.99% of Germs

GERM BLOCTM

Hand Sanitizer

Lotion

8 fl. oz. (237 ml)

PRINCIPAL DISPLAY PANEL

GERM BLOC®

KILLS 99.99% GERMS

ALCOHOL-FREE

HAND SANITIZER

LOTION

Net Contents: 1 GALLON

INGREDIENTS AND APPEARANCE

GERM BLOC HAND SANITIZER

benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69243-0610
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)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SOY PROTEIN (UNII: R44IWB3RN5)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
JOJOBA OIL (UNII: 724GKU717M)
SORBIC ACID (UNII: X045WJ989B)
EDETATE SODIUM (UNII: MP1J8420LU)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69243-0610-1	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
2	NDC:69243-0610-2	44 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
3	NDC:69243-0610-3	89 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
4	NDC:69243-0610-4	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
5	NDC:69243-0610-5	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
6	NDC:69243-0610-6	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
7	NDC:69243-0610-7	799 mL in 1 BAG; Type 0: Not a Combination Product	10/01/2014
8	NDC:69243-0610-8	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2014
9	NDC:69243-0610-9	354.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2014

GERM BLOC HAND SANITIZER

benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69243-0910
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)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SOY PROTEIN (UNII: R44IWB3RN5)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
JOJOBA OIL (UNII: 724GKU717M)
EDETATE SODIUM (UNII: MP1J8420LU)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69243-0910-1	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
2	NDC:69243-0910-2	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
3	NDC:69243-0910-3	295 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
4	NDC:69243-0910-4	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2014

Labeler - Willspeed Technologies LLC (019063540)

Revised: 1/2022

Document Id: 46dcde68-fcd6-4d94-8a6a-082ca39e07e6

Set id: 5743e2d7-7721-4b9a-9b53-8c4700841460

Version: 5

Effective Time: 20220114

Search by Drug Name or NDC

NDC 69243-0610-03 Germ Bloc Hand Sanitizer 0.0013 g/mL Details

Germ Bloc Hand Sanitizer 0.0013 g/mL

Product Information

Package

Package Images

NDC 69243-0610-03 (69243061003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5743e2d7-7721-4b9a-9b53-8c4700841460 Details

SPL UNCLASSIFIED SECTION

Active Ingredient

Purpose

Uses

Warnings

Do not use in the eyes.

Stop use and ask a doctor

Keep out of reach of children.

Directions

Inactive Ingredients

Active Ingredient

Purpose

Uses

Warnings

Do not use in the eyes.

Stop use and ask a doctor

Keep out of reach of children.

Directions

Inactive Ingredients

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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