INSTANT HAND SANITIZER- instant hand sanitizer gel 
Acessory Myxx LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer

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

Ethyl alcohol 70%-75%

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

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

To clean hands and fight bacteria on that skin

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

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

8932CM 56ml.jpg8940CM 56ml.jpg8944CM 500ml front.jpg72619-2020-4 front.jpgHC Photo 4.jpg3ml packet back label.jpgBack Label 8944CM.jpgScan_0001.jpgBack Label for 56ml.jpg

INSTANT HAND SANITIZER 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72619-2020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72619-2020-156 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
2NDC:72619-2020-2500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/18/2020
3NDC:72619-2020-43 mL in 1 PACKET; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
INSTANT HAND SANITIZER 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72619-1219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72619-1219-32.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2018
2NDC:72619-1219-256 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/10/2018
INSTANT HAND SANITIZER 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72619-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72619-1001-32.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/10/2018
Labeler - Acessory Myxx LLC (080553023)
Establishment
NameAddressID/FEIBusiness Operations
Leeds (China) Biotechnology Co., Ltd416037073manufacture(72619-2020)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(72619-1219)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD544493972manufacture(72619-1001)

Revised: 5/2020
Document Id: a600b25b-be74-6333-e053-2a95a90a31c1
Set id: a600bf1d-2afe-b062-e053-2995a90adcb0
Version: 3
Effective Time: 20200519
 
Acessory Myxx LLC