OTC Medication Information: HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Wild Berry With Silicon Holder

HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS WILD BERRY WITH SILICON HOLDER- 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.

​Drug Facts

​Active ingredient

Ethyl alcohol 70% V/V

​Purpose

Antiseptic

​Uses

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

​Warnings

F lammable, 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.

​Other information

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

​Inactive ingredients

acrylates (c10-30 alkyl acrylate crosspolymer), benzophenone-3, carbomer, cellulose, D&C Violet No. 2, fragrance, glycerin, hydroxypropyl methylcellulose, lactose, retinyl palmitate (vitamin A palmitate), tocopheryl acetate (vitamin E acetate), triethanolamine, water (aqua).

​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

Manufactured for
Sukhtian Households and Toiletries Manufacturing Co.
by: Sukhtian Pharmaceutical Manufacturing
Na’ur-Zaboud, AlQuds Street,
P.O.BOX 1027, Amman, Jordan 11710.
Made in Jordan

Packaging

HiGeen-027
(click image for full-size original)

HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS WILD BERRY WITH SILICON HOLDER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71490-027
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
OXYBENZONE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POWDERED CELLULOSE
D&C VIOLET NO. 2
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71490-027-03 50 mL in 1 BOTTLE None
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 Operations
SUKHTIAN PHARMACEUTICAL MANUFACTURING 850389249 manufacture (71490-027)

Revised: 02/2023 SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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