MOISTURIZER HAND SANITIZER- benzalkonium chloride solution

MOISTURIZER HAND SANITIZER by

Drug Labeling and Warnings

MOISTURIZER HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Rinati Skin, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIMICROBIAL

USE

FOR HAND SANITIZING TO DECREASE BACTERIA ON THE SKIN.

RECOMMENDED FOR REPEATED USE.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

IN CASE OF EYE CONTACT, FLUSH EYES WITH WATER. STOP USE AND ASK A DOCTOR IF IRRITATION, OR REDNESS DEVELOPS OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP.

DIRECTIONS

SHAKE WELL BEFORE USE.

SPRAY A SMALL AMOUNT OF PRODUCT INTO PALM OF HAND.

RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS.

RUB HANDS TOGETHER BRISKLY UNTIL DRY.

INACTIVE INGREDIENTS

WATER, PROPYLENE GLYCOL, LINUM USITATISSIMUM (FLAX) SEED EXTRACT, OCIMUM TENUIFLORUM LEAF EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, GLUCONOLACTONE, CITRIC ACID, SODIUM BENZOATE, EUCALYPTUS GLOBULUS OIL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOISTURIZER HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76849-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FLAX SEED (UNII: 4110YT348C)
OCIMUM TENUIFLORUM TOP (UNII: 34T63W8ULS)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76849-101-11	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/04/2020

Labeler - Rinati Skin, LLC (109530208)

Establishment
Name	Address	ID/FEI	Business Operations
Rinati Skin, LLC		109530208	manufacture(76849-101)