PURO ANTIBACTERIAL WASH FOAM- chloroxylenol solution
CWGC LA Inc.

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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CWGC - Puro Antibacterial Wash Foam (70415-401)

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

Uses

For handwashing to reduce bacteria on the skin

Warnings

For external use only

When using this product

Avoid contact with eyes. In case of eye contact, flush with water

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rihgt away.

Directions

Apply foaming cleanser to dry hands
Rub hands together to spread lather
Wash for 15-20 seconds
Rinse & dry hands thoroughly

Inactive ingredients

Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, SODIUM C14-16 OLEFIN SULFONATE, Hydrogenated castor Oil, DMDM Hydantoin, Citric Acid, Fragrance, FD&C Blue No.1, FD&C Yellow No.5.

Puro_Antibacterial_HS871161_sample-label

PURO ANTIBACTERIAL WASH FOAM
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-401
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70415-401-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/04/2016

Labeler - CWGC LA Inc. (034967904)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Gotdya Fine Chemical Co., Ltd.		551470189	manufacture(70415-401)

Revised: 1/2022

Document Id: d4b824bc-da21-3d78-e053-2a95a90a7141

Set id: 013a36fa-5a9a-46ea-b9d0-ac366257612e

Version: 6

Effective Time: 20220103

CWGC LA Inc.