HAND SANITISER: Package Insert and Label Information

HAND SANITISER- isopropyl alcohol liquid
Jinhua Emilan Cosmetics Factory

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 between 15-30°C (59-86°F)
●Avoid freezing and excessive heat above 40°C (104°F)

Glycerin,hydrogen peroxide,purified water USP

1.Place enough product on hands to cover all surfaces. Rub hands together until dry.
2.Supervise children under 6 vears of age when using this product to avoid swallowing.

isopropyl alcohol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

For external use only. Flammable. Keep away from heat or flame

label
(click image for full-size original)

HAND SANITISER
isopropyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54665-001
Route of Administration EXTRACORPOREAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 225 mL in 300 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
HYDROGEN PEROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54665-001-01 300 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/29/2020
Labeler — Jinhua Emilan Cosmetics Factory (546656775)
Establishment
Name Address ID/FEI Operations
Jinhua Emilan Cosmetics Factory 546656775 manufacture (54665-001)

Revised: 06/2020 Jinhua Emilan Cosmetics Factory

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