ASSURED- benzalkonium chloride swab

ASSURED by

Drug Labeling and Warnings

ASSURED by is a Otc medication manufactured, distributed, or labeled by INDELPA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.125%

PURPOSE

Antibacterial

USE

Decreases bacteria on skin.

DO NOT USE

If you are allergic to any of the ingredients

WHEN USING

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

STOP USE

If irritation or rash develops and continues for more than 72 hours

ASK DOCTOR

If irritation or rash develops and continues for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center rigth away.

INDICATIONS & USAGE

INSTRUCTIONS FOR USE

To dispense wipe: Peel back front label slowly. Remove wipes.

To reseal pouch: Firmly run thumb over the label.

STORAGE AND HANDLING

Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

INACTIVE INGREDIENT

Water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Vitamin E, Methylchloroisothiazolinone, Aloe Extract, Tetrasodium EDTA.

DOSAGE & ADMINISTRATION

Dosage: Swab

Administration: Topical

SUMMARY OF SAFETY AND EFFECTIVENESS

Assured TM Antibacterial Wet Wipes kills germs and bacteria, cleans and freshens your skin and gently wipes away perspiration and odor.

With moisturizing formula containing Aloe Vera and Vitamin E, Assured TM Antibacterial Wet Wipes are soft and gentle, and helping to nourish your skin as you freshen up.

This travel pack is convenitent to take along for use anytime or anywhere.

ASSURED
Antibacterial
Wet Wipes
Hand & face moisturizing towelettes

For hands and face
Ideal for travling
Moisturizing
Thick and soft cloths
Fresh scent

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70697-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.125 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	98.54 mg  in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 mg  in 100 mg
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.3 mg  in 100 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.01 mg  in 100 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mg  in 100 mg
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)	0.2 mg  in 100 mg
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	0.1 mg  in 100 mg
EDETATE SODIUM (UNII: MP1J8420LU)	0.03 mg  in 100 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.018 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70697-800-03	3 in 1 BAG	06/10/2016
1		10 in 1 PACKAGE
1		3 mg in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70697-800-04	40 in 1 PACKAGE	06/10/2016
2		0.375 mg in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70697-800-05	20 in 1 PACKAGE	06/10/2016
3		0.375 mg in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 70697-800-06	2 in 1 PACKAGE	06/10/2016
4		15 in 1 PACKAGE
4		2 mg in 1 POUCH; 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	part333E	06/10/2016

Labeler - INDELPA, S.A. DE C.V. (811072487)

Registrant - INDELPA, S.A. DE C.V. (811072487)

Establishment
Name	Address	ID/FEI	Business Operations
INDELPA, S.A. DE C.V.		811072487	manufacture(70697-800) , analysis(70697-800) , pack(70697-800) , label(70697-800)