SANITIZERX- hand sanitizer gel gel 
Guangzhou caolvxiang Biotechnology Co.,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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78414-004
HAND SANITIZER GEL

Active Ingredient(s)

Ethyl Alcohol75%

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 reach of children If swallowed get medical help or contact a Poison Control Center right away

When using this product keep out of eyes, ears, and mouth. In case of contact with eyesrinse eye thoroughly with water.

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

Do not use

/

WHEN USING SECTION

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyesrinse eye thoroughly with water.

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

STOP USE

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

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

Inactive ingredients

purified water
glycerin
Hydrogen peroxide

Package Label - Principal Display Panel

78414-003-02 59ml

SANITIZERX 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78414-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
1,1-BIS(TERT-BUTYLPEROXY)CYCLOHEXANE (UNII: JK62J3E3Q4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78414-004-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - Guangzhou caolvxiang Biotechnology Co.,Ltd (547949400)
Registrant - Guangzhou caolvxiang Biotechnology Co.,Ltd (547949400)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou caolvxiang Biotechnology Co.,Ltd547949400manufacture(78414-004)

Revised: 9/2020
Document Id: ae4bbdd7-e807-f803-e053-2995a90a9dbe
Set id: ae392a71-b14f-7c86-e053-2a95a90aa048
Version: 2
Effective Time: 20200901
 
Guangzhou caolvxiang Biotechnology Co.,Ltd