KONIX HAND SANITIZER GEL- konix hand sanitizer gel gel
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS

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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KONIX Hand Sanitizer Gel

Active Ingredient(s)

Ethyl alcohol 70%

Purpose

Antiseptic, Hand Sanitizer Gel

Use

Uses To decrease bacteria on the skin that could cause disease

Warnings

For external use only: hands.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest

Stop use and ask a doctor if Irritation and redness develop Condition persists 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 for children under 6 year of age, use only under adult supervision Not recommended for infants

Other information

do not store above 105°F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, Isopropyl Myristate,Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

Konix Consumer sanitizer gel 30 ml

Konix Consumer sanitizer gel 50 ml

Konix Consumer sanitizer gel 85 ml

Konix Consumer sanitizer gel 100 ml

Konix Consumer sanitizer gel 150 ml

Konix Consumer sanitizer gel 200 ml

Konix Consumer sanitizer gel 250 ml

Konix Consumer sanitizer gel 500 ml

Konix Consumer sanitizer gel 1000 ml

Konix Consumer sanitizer gel 5000 ml

KONIX HAND SANITIZER GEL
konix hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73107-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73107-104-13	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
2	NDC:73107-104-14	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
3	NDC:73107-104-15	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
4	NDC:73107-104-16	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
5	NDC:73107-104-17	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
6	NDC:73107-104-18	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
7	NDC:73107-104-19	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
8	NDC:73107-104-12	85 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
9	NDC:73107-104-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
10	NDC:73107-104-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/07/2020

Labeler - Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS (356325295)

Registrant - Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS (356325295)

Name	Address	ID/FEI	Business Operations
Establishment
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler		356325295	manufacture(73107-104)

Revised: 4/2020

Document Id: 5917f81c-5465-4a2a-8ec3-b72471cb9a2c

Set id: f7fde9a3-cb0b-4e57-bee8-8d381b730baf

Version: 2

Effective Time: 20200415

Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS