GOLDSHIELD 24 GS 24- benzalkonium chloride solution

GOLDSHIELD 24 by

Drug Labeling and Warnings

GOLDSHIELD 24 by is a Otc medication manufactured, distributed, or labeled by AP GOLDSHIELD LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

• GOLDSHIELD 24 ALCOHOL FREE ANTIBACTERIAL HAND FOAM RINSE contains 0.1 % benzalkonium chloride antimicrobial agent, formulated with purified water, propylene glycol, methyl anthranilate and trihydroxysilylpropyldimethyloctadecyl ammonium chloride.  Helps kill 99.99 % of germs and many common bacteria. Moisturizes and softens hands.

ACTIVE INGREDIENT

• Benzalkonium Chloride 0.1 % ------------------------------------ Antimicrobial

PURPOSE

• Antiseptic/Antimicrobial

INDICATIONS & USAGE

• For hand washing to help reduce bacteria on the skin that could cause disease.

WARNINGS

• Caution: For External Use Only.  Avoid contact with eyes. In case of contact flush with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours contact a physician.

KEEP OUT OF REACH OF CHILDREN

• Keep out of the Reach of Children. In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.

DOSAGE & ADMINISTRATION

• Directions:  Foam onto palm, massage into hands and fingernails and air dry. Children use with supervision.

STORAGE AND HANDLING

• Store at room temperature not below 32 degrees F.

INACTIVE INGREDIENT

• Purified Water, Propylene Glycol, Methyl Anthranilate and Trihydroxysilylpropyldimethyloctadecyl Ammonium Chloride

PRINCIPAL DISPLAY PANEL

LABEL

INGREDIENTS AND APPEARANCE

GOLDSHIELD 24  GS 24
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40092-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40092-500-11	56.7 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/15/2017
2	NDC: 40092-500-12	113.4 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/15/2017
3	NDC: 40092-500-13	226.8 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/15/2017
4	NDC: 40092-500-14	453.6 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/15/2017
5	NDC: 40092-500-15	907.2 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/15/2017
6	NDC: 40092-500-16	204300 g in 1 DRUM; Type 0: Not a Combination Product	11/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/21/2014

Labeler - AP GOLDSHIELD LLC (829190474)