DR.PHI ADVANCED HAND SANITIZER- dr.phi advanced hand sanitizer gel 
MAMIBA

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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Dr.Phi advanced hand sanitizer

active ingredient

ethyl alcohol % 70 V/V

Indication

Reduces Transient And Resistant Flora and Decreases the Risk of Cross Contamination

Dosing Instructions and Method Of Use

Hygienic Hand Disinfection : Rub at least 3 ml into dry hands for a period of 30 sec. Ensure that hand remain moist by product during the time of application 

Surgical Hand Disinfection : Rub into dry hands and forearms for 1.5 min, keep them moist throughout application.

Skin Disinfection : wet the skin area thoroughly by applying with a sterile swab. 

Areas of Application

Hygienic and surgical hand disinfection , skin disinfection prior to injections, punctures, blood sampling , vaccinations.

Warnings 

Flashpoint : 23°C . Flammable , keep away from naked flames and sources of ignition - no smoking.

Store at room temperature .

keep out of reach of children

if swallowed get medical help or contact a poison control centre right away

Contraindications 

Do not use in or near to the eyes or open wounds

not suitable for disinfection of mucous membrane

stop use and ask a doctor if

irritation and rash appears and lasts

Instructions 

Hygienic Hand Disinfection : Rub at least 3 ml into dry hands for a period of 30 sec. Ensure that hand remain moist by product during the time of application

Surgical Hand Disinfection : Rub into dry hands and forearms for 1.5 min, keep them moist throughout application.

Skin Disinfection : wet the skin area thoroughly by applying with a sterile swab

other information

store below 110​°​F

may discolor certian fabrics or surfaces

inactive ingredients

water , glycerin , carbomer , ,aminomethyl propanol.

label 500 ml

label 1000 ml

DR.PHI ADVANCED HAND SANITIZER 
dr.phi advanced hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58161-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
May containEXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
May containFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
May containFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58161-156-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201705/01/2020
2NDC:58161-156-071000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201705/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/201705/01/2020
Labeler - MAMIBA (558528988)
Establishment
NameAddressID/FEIBusiness Operations
MAMIBA558528988manufacture(58161-156)

Revised: 9/2021
 
MAMIBA