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NDC 77071-0003-00 glanHealth Hand Sanitizer Professional 1.3 mg/mL Details

glanHealth Hand Sanitizer Professional 1.3 mg/mL

glanHealth Hand Sanitizer Professional is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Dalrada Health Products. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	77071-0003
Product ID	77071-003_ab1f6f53-f6de-6726-e053-2a95a90a99ad
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	glanHealth Hand Sanitizer Professional
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Dalrada Health Products
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 77071-0003-00 (77071000300)

Pricing Information	N/A
NDC Package Code	77071-003-00
Billing NDC	77071000300
Package	1200 mL in 1 BAG (77071-003-00)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 97e37c3a-fb7e-4b4d-a149-2596b60bb92f Details

DRUG FACTS

ACTIVE INGREDIENT:

Benzalkonium Chloride 0.13%

PURPOSE:

Antiseptic/Hand & Skin Sanitizer

USES:

Hand Sanitizer to help decrease bacteria on the skin. Recommended for repeated use.

WARNINGS:

Do not freeze
For external use only

Do not use

in ears, eyes or mouth

When using this product,

avoid contact with the eyes
In case of contact, flush eyes with water

Stop use and ask a doctor if

redness or irritation develops and persists for more than 72 hours

Keep out of reach of children

Children should be supervised when using this product.

DIRECTIONS:

Apply liberally to the palms of the hands. Rub into skin until dry. Recommended for repeated use.

INACTIVE INGREDIENTS:

1-Octadecyldimethyl (3-Triethoxysilylpropyl) ammonium chloride, Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol.

QUESTIONS?

1(855) 862-1526, Mon-Fri 9:00AM-5:00PM (PST)

Package Labeling:

INGREDIENTS AND APPEARANCE

GLANHEALTH HAND SANITIZER PROFESSIONAL

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77071-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
LAURETH-4 (UNII: 6HQ855798J)
POLIHEXANIDE (UNII: 322U039GMF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77071-003-00	1200 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2020

Labeler - Dalrada Health Products (116754421)

Revised: 7/2020

Document Id: ab1f6f53-f6de-6726-e053-2a95a90a99ad

Set id: 97e37c3a-fb7e-4b4d-a149-2596b60bb92f

Version: 2

Effective Time: 20200723