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NDC 72619-1219-01 Instant Hand Sanitizer 62 mL/100mL Details

Instant Hand Sanitizer 62 mL/100mL

Instant Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Acessory Myxx LLC. The primary component is ALCOHOL.

Product Information

NDC	72619-1219
Product ID	72619-1219_a600b25b-be74-6333-e053-2a95a90a31c1
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	Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Instant Hand Sanitizer
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Acessory Myxx LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72619-1219-01 (72619121901)

Pricing Information	N/A
NDC Package Code	72619-1219-1
Billing NDC	72619121901
Package	2.9 mL in 1 BOTTLE, PLASTIC (72619-1219-1)
Marketing Start Date	2018-10-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a600bf1d-2afe-b062-e053-2995a90adcb0 Details

Instant Hand Sanitizer

Warnings

For external use only: hands

Keep out of reach of

children.If swallowed, get

medical help or contact a

Poison Control Center right

away.

Stop use and ask a doctor

if irritation and redness

develop condition persists

for more than 72 hours

aviid contact with broken

skin do not inhale or

ingest

General Warnings

Warnings

For external use only: hands

Keep out of reach of

children.If swallowed, get

medical help or contact a

Poison Control Center right

away.

Stop use and ask a doctor

if irritation and redness

develop condition persists

for more than 72 hours

aviid contact with broken

skin do not inhale or

ingest

SPL UNCLASSIFIED SECTION

Ethyl alcohol 70%-75%

SPL UNCLASSIFIED SECTION

Use to decrease bacteria on the skin. Use on hands only.

SPL UNCLASSIFIED SECTION

Water, Aloe Barbadensis Leaf Juice,

Maltodextrin,Glycerin, Propylene

Glycol, Acrylates/C10-30 Alkyl

Acrylate Crosspolymer,

Triethanoamine, Fragrance, Lactose,

Microcrystalline Cellulose,Sucrose,

Zea Mays(Corn) starch, Ultramarine

blue CI 77007,Tocopheryl Acetate,

Hydroxypropyl Methyl Cellulose,

D&C Red NO.33, FD&C Blue No.1

SPL UNCLASSIFIED SECTION

To clean hands and fight bacteria on that skin

SPL UNCLASSIFIED SECTION

Squeeze the bottle on your hands so the liquid comes out. Rub hands together. Allow hands to dry.

SPL UNCLASSIFIED SECTION

Not intended for children under the age of 12. Please keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER

instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72619-2020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)	0.18 mL in 100 mL
WATER (UNII: 059QF0KO0R)	28.42 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.35 mL in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0001 mL in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	0.04 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.35 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72619-2020-1	56 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
2	NDC:72619-2020-2	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/18/2020
3	NDC:72619-2020-4	3 mL in 1 PACKET; Type 0: Not a Combination Product	05/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/18/2020

INSTANT HAND SANITIZER

instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72619-1219
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SUCROSE (UNII: C151H8M554)
ZEA MAYS POLLEN (UNII: 74PD8J616H)
ULTRAMARINE BLUE (UNII: I39WR998BI)
3-HEXYLOXYPROPYLENE GLYCOL (UNII: 3485P35DA4)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72619-1219-3	2.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2018
2	NDC:72619-1219-2	56 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/10/2018

INSTANT HAND SANITIZER

instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72619-1001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72619-1001-3	2.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/10/2018

Labeler - Acessory Myxx LLC (080553023)

Name	Address	ID/FEI	Business Operations
Establishment
Leeds (China) Biotechnology Co., Ltd		416037073	manufacture(72619-2020)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(72619-1219)

Name	Address	ID/FEI	Business Operations
Establishment
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD		544493972	manufacture(72619-1001)

Revised: 5/2020

Document Id: a600b25b-be74-6333-e053-2a95a90a31c1

Set id: a600bf1d-2afe-b062-e053-2995a90adcb0

Version: 3

Effective Time: 20200519

Search by Drug Name or NDC

NDC 72619-1219-01 Instant Hand Sanitizer 62 mL/100mL Details

Instant Hand Sanitizer 62 mL/100mL

Product Information

Package

Package Images

NDC 72619-1219-01 (72619121901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a600bf1d-2afe-b062-e053-2995a90adcb0 Details

Instant Hand Sanitizer

General Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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