SOLUTIONS GOLD- parachlorometaxylenol solution

Solutions Gold by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Usage

Uses

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

Warnings

Warnings

• For external use only.
• Keep out of eyes, ears, or mouth. In case of eye contact, flush eyes with water.
• Stop use and ask doctor if irritation and 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.

Keep out of reach of children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

• Wet hands with water and dispense 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.

Antiseptic Gold Hand Soap Box label

Jabon Antiseptico Dorado (#HSAG-800) PRECAUCION: Para use extemo solamonte. No utilice adentro o cerca de los ojos. Si ocurre el contacto con los cojos, enjuague a fondo con aqua por 15 minutoe. No usar si la irritacion y la rojez perists. Si la condicion persista por mas de 72 horas, consulte a un doctor. MANTENER LEJOS DE LOS NINOS Si es tragado, consigs la ayuda medica, o consulte un centro de control del venena immediatainmenta. No utilice aantro o cerca de los ojos HAZARDOUS MATERIALS IDENTICATION SYSTEM 0         Flammability Rating/Grado Flammable 1         Health Hazard Rating / Grado de risgo a la salud 0         Reactivity Rating / Grado de reactividad __  SPECIAL	(#HSAG-800) Antiseptic Gold Hand Soap Jabon Antiseptico Dorado Ultimate SOLUTIONS Janitorial chemicals	Drug Facts Active Ingredient                            Purpose Parachlorometaxylenol 0.3% w/w ..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 eyes with water. Stop use and ask doctor if irritation and 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 with water and dispense 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.		Remove the tab from the front of the bag and nozzle.			Quite la tengusta del frente de la cala. Exponga el bolse y el inyector.
				Pull the dispensing tube down.			Tire hacia abajo el tubo que dispensa.
				Place the box in the dispenser with the tube facing out. Guide nozzle into valve channel. Close cover. Push dispensing button to prime.			Coloque la caja en al dispensdor, con los revestimlantos del injector hacia fuera. Dirija al inyector en al canal de la valvula. Cierre la cublarta. Empuje al boldn que dispense a la prims.
			Rev. 1.01	Ultimate Solutions Inc. Englewood, NJ 07631		SOLUTIONS Janitorial chemicals

Antiseptic Gold Hand Soap Case

5031-404-US-CS                                                Rev 1.0

Antiseptic Gold

Hand Soap

Jabon Antiseptico Dorado

12 x 800ml

# HSAG-800                        ultimate

Ultimate Solutions Inc.

Englewood, NJ 07631                      SOLUTIOINS

201-564-3204                                     janitorial chemicals

INGREDIENTS AND APPEARANCE

SOLUTIONS GOLD 
parachlorometaxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDE (UNII: 3YXD33R71G)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
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: 58575-409-01	800 mL in 1 POUCH; Type 0: Not a Combination Product	01/02/2020
2	NDC: 58575-409-02	9600 mL in 1 CASE; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/02/2020

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd.		194718243	manufacture(58575-409)