PURE CLEAN HAND SANITIZER- hand sanitizer gel
Zhejiang Meizhiyuan Cosmetics 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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Flammable. keep away from heat and flame.

For extermal use only.

keep out of reach of children

When Using This Products. avoid contact with face,eyes and broken skin.

In case of eye contact, flush with plenty of water and seek medical advice.

Ethyl alcohol 75%

Inactive Ingredients: Water (Aqua). Triethanolamine, Carbormer, Aloe Barbadensis(Aloe Vera) Gel, Fragrance, Gilycerin, Propylene
Glycol, tocopherylAcetate (Miatamin E).

Disinfection
Sterilization
No Rinseing

Antimicrobial

label

PURE CLEAN HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54304-001
Route of Administration	EXTRACORPOREAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	39.75 mL in 53 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Product Characteristics
Color	Score
Shape	Size
Flavor	Imprint Code	pureclean
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54304-001-01	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/25/2020

Labeler - Zhejiang Meizhiyuan Cosmetics Co.,Ltd (543036597)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Meizhiyuan Cosmetics Co.,Ltd		543036597	manufacture(54304-001)

Revised: 3/2020

Document Id: a1af452f-e3c3-036e-e053-2a95a90a09c7

Set id: a1af452f-e3c2-036e-e053-2a95a90a09c7

Version: 1

Effective Time: 20200325

Zhejiang Meizhiyuan Cosmetics Co.,Ltd