75% Ethanol Disinfectant (Washing-free): Package Insert and Label Information

75% ETHANOL DISINFECTANT (WASHING-FREE)- alcohol liquid
ZHEJIANG ANJI HUABU INDUSTRIAL 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.

store in a cool, dry and ventilated place.

WATER

1.Sanitize hands: Evenly spray or apply the disinfectant to the hand once or twice with the action time of about 1 minutes to achieve the disinfection effect. Surgical hand disinfectant wipe 2 times, with the action time of about 3 minutes to achieve the disinfection

effect.
2. Skin disinfection:evenl spray the disinfectant or rub it on the skin surface 2 times,with the action time of about 3 minutes to achieve the disinfection effect.
3.surface disinfection: spray the stock solution on the surface of the object, keep it wet or wipe the surface of the object 2 times, a sound sterilization will be achieved within 5 minutes.

ALCOHOL

keep out of reach of children

Disinfection
Sterilization

1. This product is a topical disinfectant and should not be taken orally.
2. Place the product out of reach of children.
3. Inflammable, keep away from fire source.
4. Store the product in a cool, dark and dry place.
5. This product is not suitable for disinfection of fat-soluble surfaces.

label
(click image for full-size original)

75% ETHANOL DISINFECTANT (WASHING-FREE)
instant hand disinfectant (ethanol75%) liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53074-003
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
WATER
Product Characteristics
Color Score
Shape BULLET Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53074-003-01 500 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 05/29/2020
Labeler — ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD (530743277)
Establishment
Name Address ID/FEI Operations
ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD 530743277 manufacture (53074-003)

Revised: 05/2020 ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD

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