Hand Disinfection: Package Insert and Label Information

HAND DISINFECTION- alcohol gel
Zhe Jiang OPS Environmental Technology 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 container tightly closed. Store in cool dry place away from sunlight.

Deionized Water, Glycerol, Carbomer, Triethanolamine´╝îAloe Leaf Extractions

Apply small amount into your palm then rub thoroughly into both hands until dry.

Alcohol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

1.This product is a hand disinfectant. Please do not use it elsewhere. People with alcohol allergies should use it with caution. Do not swallow!
2.This product contains alcohol, Keep away from fire or flame.
3.Keep container tightly closed. Store in cool dry place away from sunlight.

label
(click image for full-size original)

HAND DISINFECTION
hand disinfection gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55059-001
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
TROLAMINE
GLYCERIN
ALOE VERA LEAF
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code economical
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55059-001-01 500 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 05/11/2020
Labeler — Zhe Jiang OPS Environmental Technology Co.,Ltd. (550593028)
Establishment
Name Address ID/FEI Operations
Zhe Jiang OPS Environmental Technology Co.,Ltd. 550593028 manufacture (55059-001)

Revised: 05/2020 Zhe Jiang OPS Environmental Technology Co.,Ltd.

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