Ultimate Solutions Antiseptic Gold Hand Soap

Ultimate Solutions Antiseptic Gold by

Drug Labeling and Warnings

Ultimate Solutions Antiseptic Gold by is a Otc medication manufactured, distributed, or labeled by Ultimate Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTIMATE SOLUTIONS ANTISEPTIC GOLD- chloroxylenol liquid 
Ultimate Solutions

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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Ultimate Solutions Antiseptic Gold Hand Soap

Drug Facts

Active Ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Uses

• Handwash to decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• For external use only.

• Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

• Stop use and ask a doctor if irritation and redness develop or if condition persists 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 with water and dipense sufficient amount of product into cupped palm of hand.
• Wash thoroughly for 15 seconds.
• Rinse under running water and dry thoroughly.

Inactive ingredients

Citric Acid, Cocamide DEA, FD&C Red 4, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water

Ultimate Solutions. Inc.

Englewood, NJ 07631

ULTIMATE SOLUTIONS ANTISEPTIC GOLD 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81571-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81571-002-27	800 mL in 1 POUCH; Type 0: Not a Combination Product	02/18/2021	05/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/18/2021	05/26/2023

Labeler - Ultimate Solutions (607993826)

Revised: 1/2023

Document Id: f279bc4e-a488-8d17-e053-2995a90a3209

34390-5

Set id: bb9fe716-4e8d-2e31-e053-2a95a90abf43

Version: 2

Effective Time: 20230102