B-GOOD HAND AND SKIN DISINFECTING AGENT- alcohol solution

B-GOOD HAND AND SKIN DISINFECTING AGENT by

Drug Labeling and Warnings

B-GOOD HAND AND SKIN DISINFECTING AGENT by is a Otc medication manufactured, distributed, or labeled by HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI, HARDAL GLOBAL CONSULTING LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

B-GOOD HAND AND SKIN DISINFECTING AGENT (ANTISEPTIC SOLUTION)

Active Ingredient(s)

Clorhexidine Digluconate 4%, Ethanol 10%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerine, Preservative, Deionized water

Package Label - Principal Display Panel

Producer

HONNES SAGLIK VE ENDUSTRIYEL URUNLERI A.S.

Cumhuriyet Mh. Karayel Sk. No:14 41420

Cayirova/KOCAELI/TURKEY

Tel.: +90 262 658 89 59

Fax: +90 262 658 80 40

www.honnes.com / info@honnes.com

T.C. SAGLIK BAKANLIGI'NIN 09.08.2019 Tarihi ve 2019/97 No'lu Izniyle Uretilmistir.

LICENSE HOLDER: HONNES SAGLIK VE ENDUSTRIYEL URUNLERI A.S.

LICENCE DATE AND NUMBER 09.08.2019-2019/97

ATTENTION, CAN BE USED EXTERNALLY, DO NOT DRINK

Use the unpacked product within 6 months. The shelf life of the product is 2 years with its mouth closed, in a cool and dry place.

INGREDIENTS AND APPEARANCE

B-GOOD HAND AND SKIN DISINFECTING AGENT 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79129-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 mg  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	10 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79129-003-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79129-003-02	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI (519777302)

Registrant - HARDAL GLOBAL CONSULTING LLC (123584960)

Establishment
Name	Address	ID/FEI	Business Operations
HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI		519777302	manufacture(79129-003)