Flash Sales 027-02 revise marketing catagory

SanitizeRx Hand Sanitizer by

Drug Labeling and Warnings

SanitizeRx Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Flash Sales Inc., Ganzhou Olivee Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITIZERX HAND SANITIZER- alcohol solution 
Flash Sales 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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Flash Sales 027-02 revise marketing catagory.

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

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

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 when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Alcohol Denat, Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Package Label - Principal Display Panel

100 mL NDC: 77944-027-02

SANITIZERX HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77944-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77944-027-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020	05/05/2021

Labeler - Flash Sales Inc. (113438654)

Establishment
Name	Address	ID/FEI	Business Operations
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(77944-027)

Revised: 5/2021

Document Id: c19f99a6-69df-cc60-e053-2a95a90a8e3f

34390-5

Set id: a67e5158-deb8-0db6-e053-2a95a90a3018

Version: 3

Effective Time: 20210505