PERSONAL CARE ANTIBACTERIAL HAND- chloroxylenol liquid 
Delta Brands & Products LLC

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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Drug Facts

Active ingredient

Chloroxylenol 0.3%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only

When using this product

■ avoid contact with the eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

■ irritation and redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ pump into hands, wet as needed ■ lather vigorously for at least 15 seconds ■ wash skin, rinse thoroughly and dry

Inactive ingredients

water (aqua), ammonium lauryl sulfate, cocamidopropyl betaine, ammonium chloride, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 40

Package Label

Package Label

PERSONAL CARE  ANTIBACTERIAL HAND
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-151
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-151-75221.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/16/2018
2NDC:72133-151-15444 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2018
Labeler - Delta Brands & Products LLC (080999173)

Revised: 4/2018
Document Id: 6a3670d8-4e5b-ec70-e053-2a91aa0a8e9c
Set id: 6a369b67-9646-6de7-e053-2a91aa0a8ff1
Version: 1
Effective Time: 20180419
 
Delta Brands & Products LLC