PLUS BRASEPT THD 6544 Drug Facts and Label

PLUS BRASEPT THD by

Drug Labeling and Warnings

PLUS BRASEPT THD by is a Otc medication manufactured, distributed, or labeled by NEWDROP NORTH AMERICA LLC, ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLUS BRASEPT THD- chloroxylenol soap 
NEWDROP NORTH AMERICA LLC

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PLUS BRASEPT THD 6544 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

• wet hands and forearms
• apply 5 milliliters (teaspoonful) or palmful to hands and forearms
• scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

PLUS BRASEPT THD

PLUS BRASEPT THD 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83318-544
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83318-544-41	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/24/2023	01/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	03/24/2023	01/31/2025

Labeler - NEWDROP NORTH AMERICA LLC (094392481)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(83318-544)

Revised: 1/2025

Document Id: 2d04778c-ec43-6a61-e063-6294a90ae449

34390-5

Set id: f7927bf2-a2ed-8006-e053-6394a90ad025

Version: 2

Effective Time: 20250131