SEA MINERALS ANTIBACTERIAL- benzalkonium chloride solution

Sea Minerals Antibacterial by

Drug Labeling and Warnings

Sea Minerals Antibacterial by is a Otc medication manufactured, distributed, or labeled by Manna Kadar Beauty Inc., XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD, Dongyang Mukang Pharmaceutical Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

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

Apply product onto your wet hands, lather and rinse with water.

Other information

Store at 15° to 30°C (59° to 86°F). Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Acrylic Acid /Acrylamidomethyl Propane Sulfonic Acid Copolymer, Cocamidopropyl Betaine, CI 17200, Citral, DMDM Hydantoin, Disodium EDTA, D-Limonene, Linalool, Parfum (Fragrance), Sea Water, Sodium Laureth Sulfate, Sodium Chloride.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEA MINERALS ANTIBACTERIAL 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78656-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
2-ACRYLAMIDO-2-METHYL-1-PROPANESULFONIC ACID (UNII: 490HQE5KI5)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
CITRAL (UNII: T7EU0O9VPP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78656-002-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020
2	NDC: 78656-002-51	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/23/2020
3	NDC: 78656-002-26	260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/23/2020
4	NDC: 78656-002-27	260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020

Labeler - Manna Kadar Beauty Inc. (078629402)

Establishment
Name	Address	ID/FEI	Business Operations
XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD		543263460	manufacture(78656-002)

Establishment
Name	Address	ID/FEI	Business Operations
Dongyang Mukang Pharmaceutical Factory		554531139	manufacture(78656-002)