GOLDSHIELD 24 ANTIBACTERIAL HAND FOAM RINSE

GOLDSHIELD 24 GS 24 - benzalkonium chloride solution
AP GOLDSHIELD LLC

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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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.

In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.

Antiseptic/Antimicrobial

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

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

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

Store at room temperature not below 32 degrees F.

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

LABEL LABEL FILE

GOLDSHIELD 24 GS 24
benzalkonium chloride solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM )	BENZALKONIUM CHLORIDE	0.001 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER	0.897 g in 1 g
PROPYLENE GLYCOL	0.09 g in 1 g
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE	0.009 g in 1 g
METHYL ANTHRANILATE	0.002 g in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:40092-500-01	56.7 g in 1 BOTTLE, DISPENSING	None
2	NDC:40092-500-02	113.4 g in 1 BOTTLE, DISPENSING	None
3	NDC:40092-500-03	226.8 g in 1 BOTTLE, DISPENSING	None
4	NDC:40092-500-04	453.6 g in 1 BOTTLE, DISPENSING	None
5	NDC:40092-500-05	907.2 g in 1 BOTTLE, DISPENSING	None
6	NDC:40092-500-06	204300 g in 1 DRUM	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/16/2011

Labeler - AP GOLDSHIELD LLC (829190474)

Revised: 12/2011 AP GOLDSHIELD LLC