8HD HAND AND SKIN SANITIZER- benzalkonium chloride liquid

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Strategia Project Management, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.
Authorization status:
OTC monograph not final
Authorization number:
72513-200-01, 72513-200-02, 72513-200-03, 72513-200-04, 72513-200-05, 72513-200-06, 72513-200-07

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8HD HAND AND SKIN SANITIZER- benzalkonium chloride liquid

Strategia Project Management, Inc.

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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8HD Hand and Skin Sanitizer

DRUG FACTS

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

Antimicrobial

USES:

Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.

WARNINGS:

For external use only.

Do not use

in eyes. If contact occurs, flush thoroughly with water.

Stop use and ask a doctor:

If irritation or redness develops, 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.

DIRECTIONS:

On dry hands, place enough product in your palms to thoroughly cover the targeted area. Rub briskly

until entirely dry.

Inactive Ingredients:

Water, Hydrated Silica Complex

Package Labeling:72513-200-01

Package Labeling:72513-200-02

Package Labeling:72513-200-03

Package Labeling:72513-200-04

Package Labeling:72513-200-05

Package Labeling:72513-200-06

Package Labeling:72513-200-07

8HD HAND AND SKIN SANITIZER

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72513-20 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 .13 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

0 .0 4 g in 10 0 mL

Strategia Project Management, Inc.

WATER (UNII: 0 59 QF0 KO0 R)

9 9 .8 3 g in 10 0 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:72513-20 0 -

29 .57 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/16 /20 20

2

NDC:72513-20 0 -

59 .14 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/16 /20 20

3

NDC:72513-20 0 -

10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/16 /20 20

4

NDC:72513-20 0 -

378 5.41 mL in 1 JUG; Type 0 : No t a Co mbinatio n Pro duct

12/16 /20 20

5

NDC:72513-20 0 -

20 8 19 8 mL in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

12/16 /20 20

6

NDC:72513-20 0 -

10 40 9 8 8 .2 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

12/16 /20 20

7

NDC:72513-20 0 -

1249 18 5.9 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

12/16 /20 20

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

12/16 /20 20

Labeler -

Strategia Project Management, Inc. (054047254)

Revised: 12/2020

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