ANTISEPTIC WIPES- benzalkonium chloride (0.115%) cloth 
Flex Beauty Labs

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.

----------

Germout- Wet Wipes Antibaterial

Active ingredients

Benalkonium chloride (0.115%)

Purpose

Antiseptic

Use

Use to reduce bacteria on the skin

Warnings

For external use only

Do Not Use

Do not use if you are allegic to any of the ingredients.

When using this product 

When using this product do not use in or near eyes.

In cases of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children.

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

Directions:

Other information

store below 110°F (43°C) May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Aloe barbadensis leaf juice, Fragrance, 4Na EDTA,Propylene Glycol. sorbito

principal display panel

wipes3wipes2wipes1

ANTISEPTIC WIPES 
benzalkonium chloride (0.115%) cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SORBITOL (UNII: 506T60A25R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72308-028-2020 in 1 PACKAGE08/03/2020
11 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
2NDC:72308-028-4040 in 1 PACKAGE08/03/2020
21 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
3NDC:72308-028-8080 in 1 PACKAGE08/03/2020
31 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2020
Labeler - Flex Beauty Labs (080858917)

Revised: 8/2020
Document Id: ac0daaf1-be48-f6e3-e053-2995a90ad683
Set id: 7d7b42b4-df85-4995-be55-6611526993f8
Version: 2
Effective Time: 20200804
 
Flex Beauty Labs