HAND SANITIZER- hand sanitizer gel 
Guangzhou Mizhuangmifang Biotechnology Co. , Ltd.

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

Active Ingredient

Ethyl Alcohol 75.0%

Purpose

Antimicrobial.

Uses

Hand Sanitizer to help reduce bacteria on skin

WARNINGS

Flammable.Keep away from fire or flame.For external use only.

When Using this product

do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reah for children.If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other Information

Store below 106°F.(41℃)

May discolor certain fabrics or surfaces.

INACTIVE INGREDIENTS

Propanediol, Carbomer,2, 2', 2”-nitrilotriethanol,4-chloro-3, 5-xylenol, Aqua.

Package Label - Principal Display Panel

100 ml label 300 ml label 500 ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74444-001
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
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
PROPANEDIOL (UNII: 5965N8W85T)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74444-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
2NDC:74444-001-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
3NDC:74444-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/09/2020
Labeler - Guangzhou Mizhuangmifang Biotechnology Co. , Ltd. (418737595)
Registrant - Guangzhou Mizhuangmifang Biotechnology Co. , Ltd. (418737595)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Mizhuangmifang Biotechnology Co. , Ltd.418737595manufacture(74444-001)

Revised: 5/2020
Document Id: a537968c-3cf9-fc3b-e053-2995a90ab4cf
Set id: a538f000-592e-9248-e053-2995a90a6d48
Version: 1
Effective Time: 20200509
 
Guangzhou Mizhuangmifang Biotechnology Co. , Ltd.