ASSURED ANTISEPTIC WET WIPES VITAMIN E AND ALOE- benzalkonium chloride liquid
Greenbrier International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ASSURED Antiseptic Wet Wipes Vitamin E and Aloe

Active Ingredient

Benzalkonium chloride 0.115%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only

Do not use

in the eyes
if irritation develops

When using this product

Keep out of eyes, if contact occures, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation develops. Consult a doctor if irritation persists for more than 72hrs.

Keep out of the reach of children

If swallowed, seek medical attention or contact Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.
discard wipe in trash receptacle after use.
do not flush.

Inactive ingredients

water, aloe vera (aloe barbadensis) leaf extract, propylene, glycol, glycerin, phenoxyethanol, disodium, cocoamphodiacetate, polysorbate 20, sorbitol, disodium EDTA, tocopherol acetate, fragance.

ASSURED Antiseptic Wet Wipes Vitamin E and Aloe

60countlabel

75countlabel

ASSURED ANTISEPTIC WET WIPES VITAMIN E AND ALOE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-5111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.115 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:33992-5111-2	75 in 1 CANISTER	08/19/2013
1		3.2 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC:33992-5111-1	60 in 1 CANISTER	08/19/2013
2		3.2 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/19/2013

Labeler - Greenbrier International, Inc. (610322518)

Registrant - Hangzhou Zhongbo Industrial Co., Ltd (421265530)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Zhongbo Industrial Co., Ltd		421265530	manufacture(33992-5111)