YOUZHI Hand Sanitizer: Package Insert and Label Information

YOUZHI HAND SANITIZER- alcohol gel
Hubei Mulan Tongda 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.

Keep it sealed and store it in a cool, dry,well-ventilated environment away from light.

CARBOMER 940

TRIETHANOLAMINE

PURIFIED WATER

1.Hand Antisepsis: Apply the gel evenly on hand 1-2 times and allow action for one minute whereas surgical hand disinfection entails respective two times and 3 minutes.
2.2.Skin Antisepsis:Apply the gel evenly on the skin 2 times and allow action for 3 minutes.

Ethanol

Disinfection
Sterilization
No Rinseing

keep out of children

1.The disinfectant is for external use only! Keep out of the reach of the children!
2.It’s flammable. Keep it away from flames.
3.Individuals allergic to alcohol should use the product cautiously.
4.Keep it sealed and store it in a cool, dry,well-ventilated environment away from light.
5.Inappropriate for disinfecting the surface of the lipid-soluble object.

label

YOUZHI HAND SANITIZER
youzhi hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53023-001
Route of Administration EXTRACORPOREAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 375 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CUPRIC BIS(TRIETHANOLAMINE)
WATER
Product Characteristics
Color blue Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53023-001-01 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/15/2020
Labeler — Hubei Mulan Tongda Technology Co., Ltd (530237426)
Establishment
Name Address ID/FEI Operations
Hubei Mulan Tongda Technology Co., Ltd. 530237426 manufacture (53023-001)

Revised: 04/2020 Hubei Mulan Tongda Technology Co., Ltd

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