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NDC 77071-0007-00 glanHealth Sanitizing Body Advanced 1.3 mg/mL Details

glanHealth Sanitizing Body Advanced 1.3 mg/mL

glanHealth Sanitizing Body Advanced is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Dalrada Health Products. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	77071-0007
Product ID	77071-007_acd6d1ac-9ab8-5fcf-e053-2a95a90aca4d
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 Body Advanced
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
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 77071-0007-00 (77071000700)

Pricing Information	N/A
NDC Package Code	77071-007-00
Billing NDC	77071000700
Package	59 mL in 1 BOTTLE (77071-007-00)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 499f3b5c-f0ba-4353-b0ac-24750089cb40 Details

DRUG FACTS

ACTIVE INGREDIENT:

Benzalkonium Chloride 0.13%

PURPOSE:

Spray sanitizer for the skin and body

USES:

First aid anti-microbial, topical sanitizer, and antiseptic spray that helps eliminate harmful germs and bacteria on the skin and body. For external use only. For lasting protection, repeated use is recommended.

DIRECTIONS:

Spray liberally over the body and personal clothing for protection. Recommended for repeated application. Product is safe on all material and fabrics.

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.

INACTIVE INGREDIENTS:

Aloe Barbadensis leaf extract, Aqua, Citric Acid, Laureth-4, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

QUESTIONS?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

GLANHEALTH SANITIZING BODY ADVANCED

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77071-007
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)
LAURETH-4 (UNII: 6HQ855798J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77071-007-00	59 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: 8/2020

Document Id: acd6d1ac-9ab8-5fcf-e053-2a95a90aca4d

Set id: 499f3b5c-f0ba-4353-b0ac-24750089cb40

Version: 2

Effective Time: 20200814