Fresh Basics Foaming Hand Sanitizer

Fresh Basics Foaming Hand Sanitizer by

Drug Labeling and Warnings

Fresh Basics Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by 3b International Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRESH BASICS FOAMING HAND SANITIZER- benzalkonium chloride liquid 
3b International Limited Liability Company

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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Fresh Basics Foaming Hand Sanitizer

DRUG FACTS

Active Ingredient

Benzalkonium Chloride 0.11% W/V

Purpose

Antimicrobial

USES

• For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

WARNINGS

• For external use only. Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor

if skin irritation develops.

Keep out of reach of children.

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

INACTIVE INGREDIENTS

Aqua, Glycerin, PEG/PPG-20/20 Dimethicone, Phenoxyethanol, Aloe Barbadensis Leaf Extract, parfum.

DIRECTIONS

• Pump a small amount of foam into palm of hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Package Labeling:300ml

FRESH BASICS FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80550-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80550-004-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2020	07/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/25/2020	07/30/2022

Labeler - 3b International Limited Liability Company (962958000)

Revised: 1/2022

Document Id: d56595a2-aca4-e08a-e053-2a95a90ae00c

34390-5

Set id: 8870fe25-3fa8-47d8-97f2-1b4985029c7d

Version: 3

Effective Time: 20220112

 

3b