HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS FOR KIDS AND ADULTS BITTY AND MITTY- ethyl alcohol gel

HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Bitty and Mitty by

Drug Labeling and Warnings

HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Bitty and Mitty by is a Otc medication manufactured, distributed, or labeled by SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 (c10-30 alkyl acrylate crosspolymer), benzophenone-3, carbomer, cellulose, D&C Yellow No.10, FD&C Blue No. 1, fragrance, glycerin, hydroxypropyl methylcellulose, lactose, retinyl palmitate (vitamin A palmitate), tocopheryl acetate (vitamin E acetate), triethanolamine, 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.

SPL UNCLASSIFIED SECTION

NO WATER
NO SOAP

Manufactured by:
Sukhtian Households and Toiletries Manufacturing Co. Al Hizam street, Abu Alanda, Amman, Jordan 11118
P.O.Box : 1027

Made in Jordan

Packaging

INGREDIENTS AND APPEARANCE

HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS FOR KIDS AND ADULTS BITTY AND MITTY 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71490-033
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
OXYBENZONE (UNII: 95OOS7VE0Y)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71490-033-05	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/18/2017

Labeler - SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) (557666494)

Establishment
Name	Address	ID/FEI	Business Operations
SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)		557666494	manufacture(71490-033)