GOLDSHIELD 24 GS 24- benzalkonium chloride solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
AP GOLDSHIELD LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Antiseptic/Antimicrobial - For hand washing to help reduce bacteria on the skin that could cause disease.
Authorization status:
OTC monograph not final
Authorization number:
40092-500-11, 40092-500-12, 40092-500-13, 40092-500-14, 40092-500-15, 40092-500-16

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.

----------

DRUG FACTS

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.

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

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

GOLDSHIELD 24 GS 24

benzalkonium chloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:40 0 9 2-50 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .0 0 1 g

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

DIMETHYLO CTADECYL( 3 -( TRIMETHO XYSILYL) PRO PYL) AMMO NIUM CHLO RIDE (UNII: IQ36 O8 5WQ4)

METHYL ANTHRANILATE (UNII: 9 8 1I0 C1E5W)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:40 0 9 2-50 0 -

56 .7 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 17

2

NDC:40 0 9 2-50 0 -

113.4 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 17

3

NDC:40 0 9 2-50 0 -

226 .8 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 17

4

NDC:40 0 9 2-50 0 -

453.6 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 17

5

NDC:40 0 9 2-50 0 -

9 0 7.2 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 17

6

NDC:40 0 9 2-50 0 -

20 430 0 g in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

11/15/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

11/21/20 14

AP GOLDSHIELD LLC

Labeler -

AP GOLDSHIELD LLC (829190474)

Revised: 6/2020

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