Strike Bac Antibacterial Handsoap

Strike Bac Antibacterial Handsoap by

Drug Labeling and Warnings

Strike Bac Antibacterial Handsoap by is a Otc medication manufactured, distributed, or labeled by Genlabs Corporation, Morgan Gallacher. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STRIKE BAC ANTIBACTERIAL HANDSOAP- chloroxylenol gel 
Genlabs Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Strike Bac Antibacterial Handsoap

Drug Facts

Active ingredients

Chloroxylenol 0.25%

Purpose

Antiseptic

Use

• for handwashing to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only

Do not use

in the eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if

irritation or redness develop, 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

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

Inactive ingredients

5-Chloro-2-Methyl-4-Isothiazolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, D&C Red # 33, Fragrance, Glycerin, Glycol Distearate, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride, Sodium Laureth Sulfate, Water.

Strike Bac Antibacterial Handsoap

STRIKE BAC ANTIBACTERIAL HANDSOAP 
chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62569-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62569-003-00	1 in 1 CARTON	02/08/2023
1		473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/08/2023	07/15/2024

Labeler - Genlabs Corporation (064594260)

Registrant - Genlabs Corporation (064594260)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher		028311595	manufacture(62569-003)

Revised: 1/2024

Document Id: ab0388c9-2682-4b06-9294-019e3490ce89

34390-5

Set id: 38467a1c-e4e2-4d7f-a40d-e5408a5355ab

Version: 2

Effective Time: 20240110