DR.PHI ADVANCED HAND SANITIZER gel

Dr.Phi Advanced Hand sanitizer by

Drug Labeling and Warnings

Dr.Phi Advanced Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by MAMIBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

ethyl alcohol % 70 V/V

indication

reduces transient and resistant flora and decreases the risk of cross infection

Dosinf instructions and method of use 

Hygienic hand disinfection : rub at least 3 ml into dry hands for a period of 30 sec., Ensure that hands reamain moist by product during the time of application.

Surgical hand disinfection: Rub into dry hands and forearms for 1.5 min. keeping them moist throughout application.

skin disinfection : wet the skin area thouroughly by applying with a sterile swab

areas of applications

hygienic and surgical hand disinfection , skin disinfection prior to injections, punctures, blood sampling, vaccination.

warnings

flamable , keep away from naked flames and sources of ignition - no smoking 

store at room temperature 

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

contraindications 

not suitable for disinfection of mucous membranes

do not use in or near the eyes or open wound 

stop use and ask a doctor if

irritation and rash appears and lasts

directions

place enough prduct on your palm to thoroughly cover your hands

rub hands together until dry

other information

store below 110​°​ ​​F

may discolor certian fabrics or surfaces

inactive ingredients

purified water , glycerin , carbomer , Aminomethyl propanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58161-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58161-156-17	10 in 1 CARTON	03/01/2020
1	NDC: 58161-156-16	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 58161-156-19	10 in 1 CARTON	03/01/2020
2	NDC: 58161-156-18	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2020

Labeler - MAMIBA (558528988)

Establishment
Name	Address	ID/FEI	Business Operations
MAMIBA		558528988	manufacture(58161-156)