SANITIZER REFRESHING GEL- alcohol gel 
AEGIS SYSTEM 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.

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Ethyl alcohol

Water
Carbomer
Glycerin
Tea tree leaf Oil
Lavender Oil
Lemonglass Oil

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

• Keep Out of Reach of Children.

■ Pour a small amount into hands, spread evenly and rub into the skin

for topical use only

label

SANITIZER REFRESHING GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78423-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78423-0004-14000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/01/2020
2NDC:78423-0004-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - AEGIS SYSTEM CO.,LTD (694802962)
Registrant - AEGIS SYSTEM CO.,LTD (694802962)
Establishment
NameAddressID/FEIBusiness Operations
AEGIS SYSTEM CO.,LTD694802962manufacture(78423-0004)

Revised: 6/2020
Document Id: a6fd89c0-8354-f1df-e053-2995a90a26ab
Set id: a6fd89c0-8353-f1df-e053-2995a90a26ab
Version: 1
Effective Time: 20200601
 
AEGIS SYSTEM CO.,LTD