GERM OUT ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
Flex Beauty Labs LLC

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.

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Germ Out Antibacterial Wet Wipes

DRUG FACTS

Active Ingredients

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

To reduce bacteria on the skin.

Warnings

For external use only.

DO NOT USE

if you are allergic to any of the ingredients.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

Adults and children over 2 years of age: Apply to hands, Allow to dry without wiping. Children under 2 years of age: ask doctor prior to use.

Other information:

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

Inactive Ingredients:

Water (Aqua), Glycerin, Phenoxyethanol, Polysorbate 20, Sodium PCA, Fragrance (Parfum), Ethylhexylglycerin, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis Leaf Extract, Tetrasodium EDTA, Citric Acid.

Package Labeling:20ct

Label

Package Labeling:60ct

Box

GERM OUT ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72308-025-2020 in 1 PACKET08/15/2020
13.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:72308-025-6060 in 1 PACKET08/15/2020
23.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/15/2020
Labeler - Flex Beauty Labs LLC (080858917)

Revised: 8/2020
Document Id: ade60e88-df67-4e38-e053-2995a90a2d31
Set id: 14840d2e-7137-48b5-b2f2-6c50d41fcb4d
Version: 2
Effective Time: 20200827
 
Flex Beauty Labs LLC