HAND SANITIZER- antiseptic liquid 
GRUPO PIRRETEAM SA DE CV

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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Hand Soap Chlorexidine Gluconate

Uses

Uses

* Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

Active Ingredient

Active Ingredient Purpose

Warnings

Stop use and ask a doctor if

Stop use and ask a doctor if

* Irritation develops while using this product

Keep out of reach of children

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

Directions

Directions: Place enough product in your palm to throughly cover your hands.

Inactive Ingredients

sodium lauryl ether sulfate, cocamide DEA, EDTA disodium salt, ethylene glycol polymer, propylene glycol dicaprate, water

Questions?

QUESTIONS OR COMMENTS: Phone: (786) 599-2764. 24 hours a day, 7 days a week

Uses

Uses

* Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

Hand Soap

Label

HAND SANITIZER 
antiseptic liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78797-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE SODIUM (UNII: MP1J8420LU)  
POLIDOCANOL (UNII: 0AWH8BFG9A)  
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78797-015-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2020
Labeler - GRUPO PIRRETEAM SA DE CV (951579014)
Registrant - GRUPO PIRRETEAM SA DE CV (951579014)
Establishment
NameAddressID/FEIBusiness Operations
GRUPO PIRRETEAM SA DE CV817531659label(78797-015)
Establishment
NameAddressID/FEIBusiness Operations
KUII PRODUCTOS DE LIMPIEZA SA DE CV951578840manufacture(78797-015)

Revised: 8/2020
Document Id: ae2f0675-dbe3-ab44-e053-2995a90a5a06
Set id: ae2efcf5-67b7-62b5-e053-2a95a90a4150
Version: 1
Effective Time: 20200831
 
GRUPO PIRRETEAM SA DE CV