ANTIBACTERIAL HAND SANITIZER- antibacterial hand sanitizer liquid
Jiangsu Manwei Pharmaceutical Co.,Ltd

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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Antibacterial Hand Sanitizer

Active Ingredient(s)

CHLOROXYLENOL 0.3%,SALICYLIC ACID 0.5%.

Purpose

Antiseptic, Hand Sanitizer

scope of application

applicable to hand hygiene

wet hands with water first, then take appropriate hand sanitizer in the hands to scrub,finally rinse with water.

Matters needing attention

This product is for external use only.

Do not use

It is forbidden to be taken orally. It is forbidden for people allergic to this product

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

Do not use for children under 3 years old

Directions

wet hands with water first, then take appropriate hand sanitizer in the hands to scrub,finally rinse with water.

Other information

Store in a cool and ventilated place,

Inactive ingredients

PROPYLENE GLYCOL,

ETHYL BENZOATE,

EDETATE DISODIUM ANHYDROUS,

BENZYL ALCOHOL,

GLYCOSINE,

2-(METHYLAMINO)ETHANOL,

SODIUM CHLORIDE,

WATER,

SODIUM LAURETH-3 SULFATE,

POTASSIUM HYDROXIDE

Package Label - Principal Display Panel

350 5000 250 300 3800 500

ANTIBACTERIAL HAND SANITIZER
antibacterial hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75086-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)	11 g in 100 mL
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3 g in 100 mL
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)	0.05 g in 100 mL
METHYL BENZOATE (UNII: 6618K1VJ9T)	0.2 g in 100 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	0.1 g in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.03 g in 100 mL
GLYCOSINE (UNII: D5JUH3HNWF)	2 g in 100 mL
2-(METHYLAMINO)ETHANOL (UNII: ZMQ4G4V497)	2 g in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.85 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75086-007-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
2	NDC:75086-007-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
3	NDC:75086-007-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
4	NDC:75086-007-04	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
5	NDC:75086-007-05	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
6	NDC:75086-007-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
7	NDC:75086-007-07	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
8	NDC:75086-007-08	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/20/2020

Labeler - Jiangsu Manwei Pharmaceutical Co.,Ltd (554529430)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Manwei Pharmaceutical Co.,Ltd		554529430	manufacture(75086-007)

Revised: 4/2020

Document Id: a3b3ab4d-f6d4-6d1b-e053-2a95a90a956a

Set id: a3b3ab4d-f6d3-6d1b-e053-2a95a90a956a

Version: 1

Effective Time: 20200420

Jiangsu Manwei Pharmaceutical Co.,Ltd