HAND SANITIZER- alcohol gel 
Great health companion Medical device technology group 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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hand sanitizer 75% alcohol based

ACTIVE INGREDIENT(S)

Ethyl alcohol 75% v/v.

label

Purpose

Antiseptic

Use

For use when antibacterial soap and water are not available.
Recommended for repeated use.
Hand sanitizer to help reduce illness causing bacteria on the skin.

Warnings

For external use only. Do not use on open skin wounds.
When using this product, keep out or AWAY from eyes, ears, nose and mouth. In case of unwanted, rinse thoroughly with water.
Stop use and seek help form a licensed doctor or medical professional if rash or irritation occurs as these may be signs of a serious condition or illness.
Keep out of reach of children. Do not use on children less than 2 months of age. Children under 6 years of age should be supervised when using this product to avoid swallowing.
Do not swallow or ingest. If swallowed, seek medical help and contact a Poison Control Center immediately.
Flammable. Keep away from sources of heat or fire.

May be harmful to some fabrics, wood finishes and plastics.

Do not use

on children less than 2 months of age.

on open skin wounds.e

WHEN USING

keep out of eyes,ears and mouth.In case of contact with eyes, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help per contact a Poison Control Center right away.

Directions

Open packet. Lightly squeeze the packet into the palm of your hand with enough product to cover both of hands. Rub hands together, spread product over the backs of each hand, and in between each finger.
Children under 6 years of age should be supervised when using this product.

Other Information

Store between 59-86 ℉ (15-30℃).

Avoid freezing. Avoid excessive heat above 104 ℉ (40 ℃).

Inactive ingredients

Water(Aqua), Glycerin, Aloe barbadensis leaf extract, Carbomer, Aminomethyl Propanol, Hydrogenated castor oil, Tocopheryl acetate

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL

package lable

label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78765-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 1342 (UNII: 809Y72KV36)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78765-001-013 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Great health companion Medical device technology group co., LTD (411707413)

Revised: 6/2020
Document Id: a7395fe8-3e9d-f169-e053-2a95a90a1642
Set id: a7395fe8-3e9c-f169-e053-2a95a90a1642
Version: 1
Effective Time: 20200606
 
Great health companion Medical device technology group co., LTD