ORANGE BLOSSOM LILAC AND JASMINE HAND MIST- alcohol spray

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Antica Farmacista, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Do not use - With children less than 2 months of age - On open skin wounds - Near eyes. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
80097-005-01

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ORANGE BLOSSOM LILAC AND JASMINE HAND MIST- alcohol spray

Antica Farmacista, 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.

----------

Orange Blossom Lilac and Jasmine Hand Mist

DRUG FACTS

ACTIVE INGREDIENTS

Ethyl Alcohol, Denatured 80% v/v

Purpos e

Antiseptic

USES:

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water

are not available.

WARNINGS:

For external use only. Flammable. Keep away from heat or flame.

Do not use

With children less than 2 months of age

On open skin wounds

Near eyes.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

DIRECTIONS:

Place enough product on hands to cover all surfaces.

Rub hands together until dry.

Supervise children under 6 years of age.

OTHER INFORMATION:

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS:

Purified water USP, Glycerin, Fragrance.

2 FL. OZ / 59ML

NDC: 80097-005-01

ORANGE BLOSSOM LILAC AND JASMINE HAND MIST

alcohol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 0 9 7-0 0 5

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

8 0 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Antica Farmacista, LLC

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 0 0 9 7-0 0 5-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

12/22/20 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 rt333E

12/22/20 20

Labeler -

Antica Farmacista, LLC (171114395)

Registrant -

SALON T ECHNOLOGIES INT ERNAT IONAL, INC (877118302)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PRO SKIN SOLUTIONS, INC. DBA ACTIVE COSMETICS MANUFACTURING

174120 50 6

ma nufa c ture (8 0 0 9 7-0 0 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SALON TECHNOLOGIES INTERNATIONAL, INC

8 77118 30 2

ma nufa c ture (8 0 0 9 7-0 0 5)

Revised: 12/2020

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