Guard instant hand sanitizer by AEGIS SYSTEM CO.,LTD

Guard instant hand sanitizer by

Drug Labeling and Warnings

Guard instant hand sanitizer by is a Otc medication manufactured, distributed, or labeled by AEGIS SYSTEM CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUARD INSTANT HAND SANITIZER- 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.

----------

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

GUARD INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78423-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78423-0003-1	4000 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/01/2020	06/01/2020
2	NDC: 78423-0003-2	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	06/01/2020

Labeler - AEGIS SYSTEM CO.,LTD (694802962)

Registrant - AEGIS SYSTEM CO.,LTD (694802962)

Establishment
Name	Address	ID/FEI	Business Operations
AEGIS SYSTEM CO.,LTD		694802962	manufacture(78423-0003)

Revised: 5/2020

Document Id: a6fda01d-8b1b-f946-e053-2a95a90a2617

34390-5

Set id: a6fbb74a-cbb6-0267-e053-2a95a90a698f

Version: 4

Effective Time: 20200531