ARIEL PREMIUM SUPPLY HAND SANITIZE- alcohol gel 
SHANTOU S.E.Z BAOJIE INDUSTRY 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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Ariel Premium Supply Hand Sanitizer

active ingredients

Alcohol :62% v/v. Purpose: Antiseptic

Antiseptic

hand sanitizer

use

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 note use

In children less than 2 months of age. On open skin wounds

When using this product keep out of eyes ears and mouth. In case of contact with eyes rinse eyes throughly 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 swalloed get medical help or contact a poison control center right away

Direction

Place enought 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

Water Peg-40 Castor oil Carbomer Trolamine Chloroxylenol

74913-620

ARIEL PREMIUM SUPPLY HAND SANITIZE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74913-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 36.2 mL  in 100 mL
CHLOROXYLENOL (UNII: 0F32U78V2Q) 0.3 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74913-620-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/10/2020
Labeler - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)
Registrant - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)
Establishment
NameAddressID/FEIBusiness Operations
SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD546345856manufacture(74913-620)

Revised: 5/2020
Document Id: a6c22761-6e0a-ced2-e053-2a95a90ad664
Set id: a6c20a36-d063-faa1-e053-2995a90ad228
Version: 4
Effective Time: 20200528
 
SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD