INSTANT HAND SANITIZER gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Acessory Myxx LLC, Leeds (China) Biotechnology Co., Ltd, Nantong Health & Beyond Hygienic Products Inc., NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

ACTIVE INGREDIENT

Ethyl alcohol 70%-75%

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

PURPOSE

To clean hands and fight bacteria on that skin

DOSAGE & ADMINISTRATION

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

KEEP OUT OF REACH OF CHILDREN

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Acessory Myxx LLC (080553023)

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

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

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