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NDC 77071-0000-02 glanHealth Sanitizing Advanced 1.3 mg/mL Details

glanHealth Sanitizing Advanced 1.3 mg/mL

glanHealth Sanitizing Advanced 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	77071-0000
Product ID	77071-000_aae46a9d-e6aa-631c-e053-2995a90a8dda
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 Sanitizing Advanced
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 77071-0000-02 (77071000002)

Pricing Information	N/A
NDC Package Code	77071-000-02
Billing NDC	77071000002
Package	207 mL in 1 BOTTLE (77071-000-02)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f02f81f3-130c-4202-82e4-d78a3b13bce9 Details

DRUG FACTS

ACTIVE INGREDIENT:

Benzalkonium Chloride 0.13%

PURPOSE:

Antiseptic Hand Soap

USES:

Handwash to help reduce harmful bacteria, and germs
Helps prevent corss-contamination by hand contact
Helps prevent dyring of skin
Recommended for repeated use.

WARNINGS:

For external use only

When using this product,

do not use in or near eyes

Stop use and ask a doctor if

irritation and redness develops

Keep out of reach of children

If swallowed, seek medical attention or contact a Poison Control Center immediately

DIRECTIONS:

Wet hands and wrists with clean running water
Apply appropriate amount of product
Lather and scrub hands, fingers, fingernails, curicles, and wrists thoroughly
Rinse thoroughly with running water
Dry hands completely (incomplete drying may result in chapped skin)

OTHER INFORMATION:

Store in a cool dry place below 104° F(40°C)

INACTIVE INGREDIENTS:

Aloe Barbadensis leaf extract, Aqua, Benzyl Alcohol, Citric Acid, Glycerin, Lauramidopropyl Betaine, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

QUESTIONS?

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

Package Lableing:207ml

Package Lableing:3.78L

INGREDIENTS AND APPEARANCE

GLANHEALTH SANITIZING ADVANCED

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77071-000
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77071-000-02	207 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC:77071-000-03	3780 mL in 1 BOTTLE; 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: aae46a9d-e6aa-631c-e053-2995a90a8dda

Set id: f02f81f3-130c-4202-82e4-d78a3b13bce9

Version: 2

Effective Time: 20200720