Ocean Hand Sanitizer Refill

Ocean Hand Sanitizer Refill by

Drug Labeling and Warnings

Ocean Hand Sanitizer Refill by is a Otc medication manufactured, distributed, or labeled by Mangiacotti, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCEAN HAND SANITIZER REFILL- benzalkonium chloride liquid 
Mangiacotti, Inc

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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Ocean Hand Sanitizer Refill

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

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

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

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

Inactive Ingredients

Water, cetrimonium chloride, lautrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance with essential oils

Package Labeling:

OCEAN HAND SANITIZER REFILL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42926-004
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42926-004-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020	01/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/21/2020	01/31/2023

Labeler - Mangiacotti, Inc (078850804)

Revised: 1/2023

Document Id: f189eb8a-5012-77e9-e053-2995a90a2477

34390-5

Set id: b51a1e7b-cbd3-21f2-e053-2a95a90acf0c

Version: 4

Effective Time: 20230105