HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS GOLD- ethyl alcohol gel 
SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.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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HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Gold

Drug Facts

Active ingredient

Ethyl alcohol 70% V/V

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on the skin. • recommended for repeated use.

Warnings

Flammable, keep away from fire or flame.
For external use only.
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if • irritation and redness develops. • condition persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping.
• supervise children in the use of this product.

Inactive ingredients

acrylates (ammonium methacrylate copolymer), acrylates (c10-30 alkyl acrylate crosspolymer), Carbomer, Caprylic (capric triglyceride), Cellulose, Fragrance, Glycerin, Hydroxypropyl methyl cellulose, manuka honey, Mannitol, Mica, Talc, Tocopheryl acetate (vitamin E acetate), Triethanolamine, Triethyl citrate, water (aqua).

Other information

• store at 20° to 25°C (68° to 77°F). • may discolor certain fabrics.

Questions or comments?

call   +1-419-322-4731
available from Monday to Friday (8 am – 4 pm).
You may report serious side effects to this phone number.

NO WATER
NO SOAP

With Exotic Aroma D'amore

Manufactured by:

Sukhtian Households and Toiletries Manufacturing Co. Al Hizam street, Abu Alanda, Amman, Jordan 11118

P.O.Box : 1027

Made in Jordan

Packaging

image description

HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS GOLD 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71490-029
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
AMMONIUM METHACRYLATE (UNII: J2243103QO)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LEPTOSPERMUM SCOPARIUM WHOLE (UNII: H91OP27WW5)  
MANNITOL (UNII: 3OWL53L36A)  
MICA (UNII: V8A1AW0880)  
TALC (UNII: 7SEV7J4R1U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71490-029-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/18/2017
Labeler - SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) (557666494)
Establishment
NameAddressID/FEIBusiness Operations
SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)557666494manufacture(71490-029)

Revised: 1/2021
Document Id: 4436dedd-9a83-43fe-874a-ba979167928d
Set id: 3d07ae8e-ec30-44c8-ad94-6671cd4cf7bf
Version: 2
Effective Time: 20210120
 
SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)