Compound Alcohol Hand Disinfection Gel: Package Insert and Label Information

COMPOUND ALCOHOL HAND DISINFECTION GEL- alcohol and isopropyl alcohol gel
Beijing XiDeBao Disinfection Products 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 in a dark, cooll and dry place.

Carbomer

purified water

glycerin

1. Surgical hand disinfection: for clean hands, put about 3 ml to 5 ml on palms, rub from hands to forearms, wait for 3 to 5 minutes.
2. Sanitary hand disinfection: put about 3 ml on palms,smear evenly over hands, wait for 1 minute.

Ethanol

isopropanol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

1. As external disinfectant, it could not be taken orally and shall be put beyond children’ s reach.
2. Washing-free disinfection only applies to clean hands, and fithy hands shall be washed before disinfection.
3. As it has slight stimulation to damaged skin and wound, please pay attention while using.
4. The period of use after opening is no longer than 30 days.
5. Keep it in a dark, cooll and dry place.
6. Its period of efficacy under stipulated storage conditions is 2 years.

COMPOUND ALCOHOL HAND DISINFECTION GEL hand disinfection gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52779-001 Route of Administration EXTRACORPOREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 45.6 mL in 76 mL ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 4.56 mL in 76 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER

Product Characteristics Color Score Shape Size Flavor Imprint Code XIDEBAO Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52779-001-01 76 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 05/15/2020

Labeler — Beijing XiDeBao Disinfection Products Co. Ltd. (527799822)

Establishment
Name	Address	ID/FEI	Operations
Beijing XiDeBao Disinfection Products Co. Ltd.		527799822	manufacture (52779-001)

Revised: 05/2020 Beijing XiDeBao Disinfection Products Co. Ltd.