(AENC) DISINFECTANT WATER-FREE HAND FOAM- polihexanide solution

(Aenc) Disinfectant WATER-FREE HAND FOAM by

Drug Labeling and Warnings

(Aenc) Disinfectant WATER-FREE HAND FOAM by is a Otc medication manufactured, distributed, or labeled by Yantai Dongke Lvzhiyuan Disinfection Pharmaceutical Co., Ltd., Yantai Dongke Lvzhiyuan Disinfection Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Polyhexamethy-lene Biguanidine 0.46%-0.56% w/w.

Dodecyl Dimethyl Benzyl Ammonium Chloride 0.09%-0.11% w/w.

Purpose

Antiseptic, Hand Sanitizer

Use

Suitable for hand sanitizing at hospital and home.

Warnings

Keep out of reach of children; Avoid contact with eyes; For external use only, do not swallow; Do not mix with other produts; Do not use it for other purposes; Store at room temperature and away from light.

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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

50 mL NDC: 77717-001-01

75 mL NDC: 77717-001-02

100 mL NDC: 77717-001-03

150 mL NDC: 77717-001-04

300 mL NDC: 77717-001-05

345 mL NDC: 77717-001-06

450 mL NDC: 77717-001-07

650 mL NDC: 77717-001-08

INGREDIENTS AND APPEARANCE

(AENC) DISINFECTANT WATER-FREE HAND FOAM 
polihexanide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77717-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.11 mg  in 100 mL
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF)	POLIHEXANIDE	0.56 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77717-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
2	NDC: 77717-001-02	75 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
3	NDC: 77717-001-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
4	NDC: 77717-001-04	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
5	NDC: 77717-001-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
6	NDC: 77717-001-06	345 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
7	NDC: 77717-001-07	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
8	NDC: 77717-001-08	650 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/20/2020

Labeler - Yantai Dongke Lvzhiyuan Disinfection Pharmaceutical Co., Ltd. (552685637)

Registrant - Yantai Dongke Lvzhiyuan Disinfection Pharmaceutical Co., Ltd. (552685637)

Establishment
Name	Address	ID/FEI	Business Operations
Yantai Dongke Lvzhiyuan Disinfection Pharmaceutical Co., Ltd		552685637	manufacture(77717-001)