CARE ON HAND SANITIZER GEL- alcohol gel 
WELCRON HEALTHCARE 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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70416-2001

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

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.

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, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Extract, Rosemary Extract

Package Label

500ml NDC: 70416-2001-1

100ml NDC: 70416-2001-2

CARE ON HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70416-2001
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
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LICORICE (UNII: 61ZBX54883)  
ROSEMARY (UNII: IJ67X351P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70416-2001-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/28/2020
2NDC:70416-2001-2100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/28/2020
Labeler - WELCRON HEALTHCARE CO., LTD (688301944)
Registrant - Devolver Cosmetics Co., Ltd (695733244)
Establishment
NameAddressID/FEIBusiness Operations
Devolver Cosmetics Co., Ltd695733244manufacture(70416-2001)

Revised: 11/2020
Document Id: b481647a-3cb1-ab92-e053-2995a90ad749
Set id: b059258d-f7e5-7def-e053-2a95a90ab625
Version: 2
Effective Time: 20201119
 
WELCRON HEALTHCARE CO., LTD