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 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.

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)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
May contain	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
May contain	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
May contain	FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58161-156-06	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2017
2	NDC: 58161-156-07	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2017

Labeler - MAMIBA (558528988)

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