BANEN Quick Drying Hand Disinfecting Gel: Package Insert and Label Information

BANEN QUICK DRYING HAND DISINFECTING GEL- alcohol gel
LIONSER Medical Disinfectant(Hangzhou) 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.

Ethyl alcohol

keep out of reach of children

Keep it away from light and store it in a cool and dry place.

Disinfection
Sterilization
No Rinseing

Water, Acrylates/C10-30 Alkryl Acrylate Crosspolyrmer, Triethanolamine. Fragrance

Wash hands, forearms and lower 1/3 of upper arm according to the requirements of hand hygiene standards. then rub appropriate amount of disinfectant to each part of hands. forearms and lower 1/3 of upper arm for 1-3
minutes.

This product is for extermal use only and must not be taken orally.

It should be used with caution by alcohol allergy sufferers.

Keep it away from fire as it contains ethanol.

label
(click image for full-size original)

BANEN QUICK DRYING HAND DISINFECTING GEL
hand disinfecting gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52874-003
Route of Administration EXTRACORPOREAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 350 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TROLAMINE
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code banen
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52874-003-01 500 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 03/28/2020
Labeler — LIONSER Medical Disinfectant(Hangzhou) Co., Ltd. (528749208)
Establishment
Name Address ID/FEI Operations
LIONSER Medical Disinfectant(Hangzhou) Co., Ltd. 528749208 manufacture (52874-003)

Revised: 12/2020 LIONSER Medical Disinfectant(Hangzhou) Co., Ltd.

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