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NDC 77071-0005-00 glanHealth Sanitizing hand wipes advanced 1.3 mg/mL Details

glanHealth Sanitizing hand wipes advanced 1.3 mg/mL

glanHealth Sanitizing hand wipes advanced is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Dalrada Health Products. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	77071-0005
Product ID	77071-005_ab1fa1d4-fb34-6728-e053-2a95a90a2bb0
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 hand wipes advanced
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
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 77071-0005-00 (77071000500)

Pricing Information	N/A
NDC Package Code	77071-005-00
Billing NDC	77071000500
Package	80 PATCH in 1 PACKAGE (77071-005-00) / 6.25 mL in 1 PATCH
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 514b8a76-7947-486d-9ce6-86a9f98dc2ed Details

DRUG FACTS

ACTIVE INGREDIENT:

Benzalkonium Chloride 0.13%

PURPOSE:

Antiseptic/ hand and skin sanitizer

USES:

Sanitizing hand wipes that help decrease bacteria on the skin. Recommended for single use.

WARNINGS:

DO NOT FREEZE. FOR EXTERNAL USE ONLY.

DO NOT USE

IN EARS, EYES, OR MOUTH.

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 FOR USE:

WIPE LIBERALLY OVER THE HANDS AND BODY, RUB INTO SKIN UNTIL DRY. RECOMMENDED FOR SINGLE USE.

INACTIVE INGREDIENTS:

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

QUESTIONS?

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

PACKAGE LABELING:

INGREDIENTS AND APPEARANCE

GLANHEALTH SANITIZING HAND WIPES ADVANCED

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77071-005
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)
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77071-005-00	80 in 1 PACKAGE	01/01/2020
1		6.25 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

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: ab1fa1d4-fb34-6728-e053-2a95a90a2bb0

Set id: 514b8a76-7947-486d-9ce6-86a9f98dc2ed

Version: 2

Effective Time: 20200723