ALCOHOL DISINFECTINGSPRAY by Yiwu City Ouli Cosmetics Co., Ltd. 55185-002

ALCOHOL DISINFECTINGSPRAY by

Drug Labeling and Warnings

ALCOHOL DISINFECTINGSPRAY by is a Otc medication manufactured, distributed, or labeled by Yiwu City Ouli Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL DISINFECTINGSPRAY- alcohol disinfecting liquid 
Yiwu City Ouli Cosmetics 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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55185-002

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

1.This product is fo external use only as wash-free hand cleaning and disinfection coagulation.Not for oral administration.Placed where it is inaccessible for children.

2.This product slightly irritates thedamaged skin.

3.Sealed ,and put in the cool, dry place to preserve.In the transport and stacking process, exposure to the sun should be prohibited.Stay far away from fire and baking

4.xFor 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 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 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.

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

water

Package Label - Principal Display Panel

100 ml NDC: 55185-002-01

20 ml NDC: 55185-002-02

30 ml NDC: 55185-002-03

50 ml NDC: 55185-002-04

60 ml NDC: 55185-002-05

80 ml NDC: 55185-002-06

90 ml NDC: 55185-002-07

120 ml NDC: 55185-002-08

150 ml NDC: 55185-002-09

180 ml NDC: 55185-002-10

200 ml NDC: 55185-002-11

236 ml NDC: 55185-002-12

237 ml NDC: 55185-002-13

250 ml NDC: 55185-002-14

300 ml NDC: 55185-002-15

350 ml NDC: 55185-002-16

500 ml NDC: 55185-002-17

800 ml NDC: 55185-002-18

1000 ml NDC: 55185-002-19

ALCOHOL DISINFECTINGSPRAY 
alcohol disinfecting liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55185-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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: 55185-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
2	NDC: 55185-002-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
3	NDC: 55185-002-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
4	NDC: 55185-002-04	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
5	NDC: 55185-002-05	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
6	NDC: 55185-002-06	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
7	NDC: 55185-002-07	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
8	NDC: 55185-002-08	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
9	NDC: 55185-002-09	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
10	NDC: 55185-002-10	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
11	NDC: 55185-002-11	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
12	NDC: 55185-002-12	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
13	NDC: 55185-002-13	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
14	NDC: 55185-002-14	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
15	NDC: 55185-002-15	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
16	NDC: 55185-002-16	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
17	NDC: 55185-002-17	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
18	NDC: 55185-002-18	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021
19	NDC: 55185-002-19	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020	04/21/2021

Labeler - Yiwu City Ouli Cosmetics Co., Ltd. (551858412)

Registrant - Yiwu City Ouli Cosmetics Co., Ltd. (551858412)

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu City Ouli Cosmetics Co., Ltd.		551858412	manufacture(55185-002)

Revised: 4/2021

Document Id: c0711041-30b0-1f19-e053-2995a90a9a52

34390-5

Set id: a7dd9d80-2157-57b4-e053-2995a90af32a

Version: 3

Effective Time: 20210420