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NDC 77071-0001-02 glanHealth Hand Sanitizer Advanced 1.3 mg/mL Details

glanHealth Hand Sanitizer Advanced 1.3 mg/mL

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

Product Information

NDC	77071-0001
Product ID	77071-001_b1425073-9075-6cff-e053-2a95a90a9f7d
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 Advanced
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, FOAM
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 77071-0001-02 (77071000102)

Pricing Information	N/A
NDC Package Code	77071-001-02
Billing NDC	77071000102
Package	150 mL in 1 BOTTLE (77071-001-02)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 866fbe89-0d38-4ed9-af87-3bcdf7bc1918 Details

DRUG FACTS

ACTIVE INGREDIENT:

Benzalkonium Chloride 0.13%

PURPOSE

Hand & Skin Sanitizer

USES:

GlanHealth's Advanced Hand Sanitizer provides revolutionary protection in an alcohol-free formula. The Scientifically-proven solutiion kills harmful germs, bacteria, and microbes, and gently soothes and softens skin with aloe vera. 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 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 or areas of damaged skin. Rub into skin until dry. Recommended for repeated use.

OTHER INFORMATION:

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

INACTIVE INGREDIENTS

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

QUESTIONS?

1(855) 8692-1526, Mon-Fri 9:00AM-5:00PM (PST)

Package Labeling:3.78L

Package Labeling:59mL

Package Labeling:150ml

Package Labeling:50ml

Package Labeling:500ml

Package Labeling:18.93L

INGREDIENTS AND APPEARANCE

GLANHEALTH HAND SANITIZER ADVANCED

benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77071-001
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:77071-001-00	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC:77071-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
3	NDC:77071-001-02	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
4	NDC:77071-001-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
5	NDC:77071-001-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
6	NDC:77071-001-05	18930 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: 10/2020

Document Id: b1425073-9075-6cff-e053-2a95a90a9f7d

Set id: 866fbe89-0d38-4ed9-af87-3bcdf7bc1918

Version: 4

Effective Time: 20201009