75% ALCOHOL HAND SANITIZER- ethyl alcohol liquid 
FUYUE BIO-TECHNOLOGY 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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75% ALCOHOL HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

When using this product keep out of eyes. In case of contact eyes, rinse thoroughly with water. 

Stop use and ask a doctor if irritation or redness occurs.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

Place enough product in hand palm and rub it until dry.

Inactive Ingredients

Water, Hydroxyethylcellulose, Panthenol, Fragrance

Made In Taiwan

Manufactured by FU YUE Bio-Technology Co., LTD

Packaging

IMAGE

75% ALCOHOL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81323-621
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
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81323-621-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
2NDC:81323-621-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
3NDC:81323-621-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
4NDC:81323-621-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
5NDC:81323-621-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
6NDC:81323-621-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
7NDC:81323-621-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
8NDC:81323-621-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
9NDC:81323-621-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
10NDC:81323-621-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/13/2021
Labeler - FUYUE BIO-TECHNOLOGY CO., LTD. (656370626)
Establishment
NameAddressID/FEIBusiness Operations
FUYUE BIO-TECHNOLOGY CO., LTD.656370626manufacture(81323-621)

Revised: 1/2021
Document Id: f44ad10b-565d-4832-902f-d2390ad40746
Set id: 0d2c8673-c490-4878-808c-7e6c348c4197
Version: 1
Effective Time: 20210113
 
FUYUE BIO-TECHNOLOGY CO., LTD.