AZX WELLNESS HAND SANITIZER- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
ASC Marketing LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For hand washing to decrease bacteria on the skin.
Authorization status:
OTC monograph not final
Authorization number:
73145-007-01

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AZX WELLNESS HAND SANITIZER- alcohol gel

ASC Marketing LTD

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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AZX Wellness Hand Sanitizer

DRUG FACTS

Active Ingredients:

Ethyl Alcohol 80%

Purpos e:

Antiseptic

USES

For hand washing to decrease bacteria on the skin.

WARNINGS

For external use only. Flammable. Keep away from fire or flames.

Do not use

in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or redness develop and persist for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact Poison Control Center right away. Store between 59-86°F

(15-30°C). Avoid freezing and excessive heat above 104°F (40°C).

DIRECTIONS

Wet hands thoroughly for at least 20 seconds with product and allow to dry without wiping. Supervise

children in the use of this product.

INACTIVE INGREDIENTS

GLYCERIN, HYDROGEN PEROXIDE, METHYLCELLULOSE, STERILE WATER.

Package Labeling:

AZX WELLNESS HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73145-0 0 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .8 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)

METHYLCELLULO SE, UNSPECIFIED (UNII: Z9 44H5SN0 H)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:73145-0 0 7-

378 0 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

11/21/20 20

ASC Marketing LTD

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 rt333E

11/21/20 20

Labeler -

ASC Marketing LT D (117025198)

Revised: 12/2020

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