HAND SANITIZER- alcohol gel 
Shenzhen Youmikai Technology 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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Active Ingredient(s)

Alcohol v/v 70%

Purpose

Antiseptic/ antimicrobial

Use

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

Warnings

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

Do not use

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.

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

Other information

Inactive ingredients

Water (aqua), Gycerin, Carbomer 940, Trolamine, Aloe Vera Leaf

Package Label - Principal Display Panel

100 ml NDC: 77482-001-10

100 mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77482-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.5 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77482-001-10100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - Shenzhen Youmikai Technology Co., Ltd. (403062710)
Establishment
NameAddressID/FEIBusiness Operations
UNIK Technology Shenzhen Co ltd403062710manufacture(77482-001)

Revised: 5/2020
Document Id: a5ec90fb-b587-e218-e053-2995a90a879d
Set id: a5f4a8f2-63c2-5e43-e053-2995a90a546d
Version: 1
Effective Time: 20200518
 
Shenzhen Youmikai Technology Co., Ltd.