ANTIMICROBIAL HAND- chloroxylenol soap 
AMMMM 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.

----------

AMMMM - VAQUITA ANTI-MICROBIAL HAND SOAP (Chloroxylenol 0.04%)

ACTIVE INGREDIENT

CHLOROXYLENOL 0.04%

PURPOSE

ANTIMICROBIAL

USES

WARNINGS

FOR EXTERNAL USE ONLY.

IN CASE OF CONTACT WITH EYES, FLUSH EYES WITH WATER AND SEEK MEDICAL ADVICE.

DISCONTINUE USE AND CONSULT A PHYSICIAN IF IRRITATION DEVELOPS.

CONSULT WITH A PHYSICIAN IF INGESTED.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

INACTIVE INGREDIENTS

WATER, COCAMIDOPROPYL BETAINE, AMIDES, COCO, N-(2-HYDROXYPROPYL), PCMX, RED COLOR

01B LBL (CARTON)_Antimicrobial Hand Soap 4x8_1gal

ANTIMICROBIAL HAND 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77397-103
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
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77397-103-113785 mL in 1 JUG; Type 0: Not a Combination Product07/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/16/2021
Labeler - AMMMM INC (808060680)

Revised: 7/2021
Document Id: c7a675fa-b6b6-6237-e053-2a95a90a0406
Set id: c7a685e1-4721-355b-e053-2995a90adabf
Version: 1
Effective Time: 20210721
 
AMMMM INC