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.

label
(click image for full-size original)

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.

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