THE PASTEL SHOP NATURAL CLEAN HAND SANITIZER GEL- alcohol gel 
JNJ COSTEC CO

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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Drug Facts

Alcohol

Water
Glycerin
PEG-60 Hydrogenated Castor Oil
Carbomer
Triethanolamine
Fragrance
Lavandula Angustifolia (Lavender) Water
Salvia Sclarea (Clary) Extract
Hyacinthus Orientalis (Hyacinth) Extract
Chamomilla Recutita (Matricaria) Flower/Leaf Extract
Borago Officinalis Extract
Centaurea Cyanus Flower Extract
Tocopherol
Butylene Glycol
1,2-Hexanediol
Ethylhexylglycerin

Instantly kils most common germs and bacteria without damaging skin and stop some viruses.
Great alternative when soap and water are not available.
Disposable and quick-drying.
Perfect and convenient to carry in purse, school backpacks and travel bags.

KEEP OUT OF REACH OF THE CHILDREN

Just apply it, let it dry a few seconds. No water or towels needed.

1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the
parts of body, or wounded skins (It may cause irritations)
2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,
itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.
3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact
occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin
area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly
inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product
is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed
gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina
steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified.

external use only

label

THE PASTEL SHOP NATURAL CLEAN HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78488-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78488-0001-125 mL in 1 POUCH; Type 0: Not a Combination Product06/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/06/2020
Labeler - JNJ COSTEC CO (694586192)
Registrant - JNJ COSTEC CO (694586192)
Establishment
NameAddressID/FEIBusiness Operations
JNJ COSTEC CO694586192manufacture(78488-0001) , label(78488-0001)

Revised: 6/2020
Document Id: a760c88a-52ce-0baf-e053-2995a90a212a
Set id: a760c7c0-768f-2311-e053-2995a90a885e
Version: 1
Effective Time: 20200605
 
JNJ COSTEC CO