HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS BLUE FLOWERS WITH SILICON HOLDER- ethyl alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)
INN (International Name):
ALCOHOL
Composition:
ALCOHOL 70 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic • for handwashing to decrease bacteria on the skin. • recommended for repeated use.
Authorization status:
OTC monograph not final
Authorization number:
71490-024-03

HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS BLUE FLOWERS

WITH SILICON HOLDER- 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 Blue Flowers With Silicon Holder

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 (c10-30 alkyl acrylate crosspolymer), benzophenone-3, carbomer, cellulose, 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.

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

HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS BLUE

FLOWERS WITH SILICON HOLDER

ethyl alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7149 0 -0 24

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

70 mL in 10 0 mL

Inactive Ingredients

SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)

Ingredient Name

Stre ng th

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

O XYBENZO NE (UNII: 9 5OOS7VE0 Y)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

LACTO SE, UNSPECIFIED FO RM (UNII: J2B2A4N9 8 G)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7149 0 -0 24-0 3

50 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /18 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 9 /18 /20 17

Labeler -

SUKHT IAN-HT M ( HOUSEHOLDS & T OILET RIES MFG.CO) (557666494)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)

5576 6 6 49 4

ma nufa c ture (7149 0 -0 24)

Revised: 8/2017

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