SanitizeRx Hand Sanitizer by Flash Sales Inc. / Ganzhou Olivee Cosmetic Co., Ltd. Flash Sales 027-03

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 027-03

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

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eye 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

fRONT AND bACK lABELS 300 mL NDC: 77944-027-03

SANITIZERX HAND SANITIZER
alcohol solution

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 77944-027-03	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2020

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

Labeler - Flash Sales Inc. (113438654)

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

Revised: 5/2021

Document Id: c19fa026-3f94-f029-e053-2a95a90a1463

Set id: a67ecfa7-1064-d85c-e053-2a95a90adfd3

Version: 3

Effective Time: 20210505