Baham's Bo Ocean Fresh Hand Sanitizer

Bahama Bo by

Drug Labeling and Warnings

Bahama Bo by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BAHAMA BO OCEAN FRESH HAND SANITIZER- ethyl alcohol gel 
Prime Enterprises

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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Baham's Bo Ocean Fresh Hand Sanitizer

Active Ingredient(s)

Alcohol 77% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aminomethyl Propanol, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Glycerin, Hydrogen Peroxide, PEG-6, Wate

Package Label - Principal Display Panel

3.8 mL NDC: 58443-0337-2

BAHAMA BO  OCEAN FRESH HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0337
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0337-2	3.8 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2020	07/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020	07/31/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0337) , analysis(58443-0337) , pack(58443-0337) , label(58443-0337)

Revised: 4/2022

Document Id: dbea1fc9-7a26-c705-e053-2a95a90a936b

34390-5

Set id: a70827e8-dedc-42e5-e053-2a95a90abdf4

Version: 3

Effective Time: 20220405