CLEAN WORKS HAND SANITIZER ANTIBACTERIAL- alcohol solution
Ouya Cosmetics Co., Ltd of Yiwu

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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Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antimicrobial

Use

To reduce bacteria on the skin

Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame

For external use only.

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 or redness occur and persist

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 rub until dry
For children under 6, use only under adult supervision

Other information

Do not store above 110F (43C)

May discolor some fabrics or surfaces

Inactive ingredients

Water, propylene glycol, glycerin, carbomer, aloe barbadensis leaf extract, aminomethyl propanediol, tocopheryl acetate

image description

CLEAN WORKS HAND SANITIZER ANTIBACTERIAL
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54699-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54699-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
2	NDC:54699-002-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
3	NDC:54699-002-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
4	NDC:54699-002-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
5	NDC:54699-002-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
6	NDC:54699-002-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
7	NDC:54699-002-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2020

Labeler - Ouya Cosmetics Co., Ltd of Yiwu (546464926)

Name	Address	ID/FEI	Business Operations
Establishment
Ouya Cosmetics Co., Ltd of Yiwu		546464926	manufacture(54699-002)