ASSURED- benzalkonium chloride lotion

Assured by

Drug Labeling and Warnings

Assured by is a Otc medication manufactured, distributed, or labeled by TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium chloride 0.115%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Use   decreases bacteria on skin

WARNINGS

Warnings

For external use only

Do not use

-over large areas of the body if you are allergic to any of the ingredients

When using this product avoid contact with eyes and face.

If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and

continues for more than 72 hours

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

DOSAGE & ADMINISTRATION

Directions

-for adults and children of 2 years and over use

on hands and face to clean and refresh, allow skin to air dry.

-For children under 2 years ask a doctor before using

INACTIVE INGREDIENT

Inactive ingredient

Water, propylene glycol, glycerin, cocamidopropyl

betaine, polyaminopropyl biguanide, aloe barbadensis leaf extract,

tocopheryl acetate, peg-54 hydrigenated castor oil, disodium edta,

citric acid, fragrance, methylchloroisothiazolinone,

methylsothiazolinone

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70031-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-54 HYDROGENATED CASTOR OIL (UNII: 0WZF1506N9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYL SOYATE (UNII: 808DL597QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70031-002-02	20 in 1 BAG	08/31/2016
1	NDC: 70031-002-01	.1 g in 1 PACKET; 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	08/31/2016

Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)