Fresh Basics Antibacterial Hand Sanitizing

Fresh Basics Antibacterial Hand Sanitizing by

Drug Labeling and Warnings

Fresh Basics Antibacterial Hand Sanitizing 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 ANTIBACTERIAL HAND SANITIZING- chloroxylenol soap 
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 Antibacterial Hand Sanitizing

DRUG FACTS

Active Ingredient

Chloroxylenol 0.45% V/V

Purpose

Antimicrobial

USES

• Helps eliminate bacteria on hands

WARNINGS

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

Keep out of reach of children,

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

INACTIVE INGREDIENTS

Water (Aqua), Sodium Laureth Sulfate, Cocoamidopropyl Betaine, Propylene Glycol, Ammonium Lauryl Sulfate, Cocamide DEA, Citric Acid, Disodium EDTA, Phenoxyethanol, Sodium Chloride, Aloe Barbadensis Leaf Extract, Parfum, DMDM Hydantoin

DIRECTIONS

• Wash hands and rinse.

Package Labeling:

FRESH BASICS ANTIBACTERIAL HAND SANITIZING 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80550-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	4.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80550-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2020	08/25/2022

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

Labeler - 3b International Limited Liability Company (962958000)

Revised: 1/2022

Document Id: d56515bc-4ecd-a745-e053-2995a90aac63

34390-5

Set id: fafc7e48-04b0-4cf9-b7d1-c93c7da21574

Version: 3

Effective Time: 20220112

 

3b