PURE SAFER GEL(ETHANOL)- hand sanitizer gel 
Sinbad 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

Ethyl Alcohol 70.0% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on skin.

Warnings

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

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if iffitation or rash appears and lasts.

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

Inactive ingredients

Water(Aqua), Carbomer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol, Triethanolamine, Propylene Glycol, FD&C Blue No.1, FD&C Yellow No.5

Directions:

Other Information:

Package Label - Principal Display Panel

500mL NDC: 74142-201-50

PURE SAFER GEL(ETHANOL) 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74142-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE (UNII: V5VD430YW9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74142-201-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - Sinbad Co.,Ltd (693900611)
Registrant - Sinbad Co.,Ltd (693900611)
Establishment
NameAddressID/FEIBusiness Operations
CAREPHARM694639821manufacture(74142-201)

Revised: 5/2020
Document Id: a6852742-aded-5f7b-e053-2995a90af5ae
Set id: a2231488-1f6f-b40b-e053-2a95a90ad26c
Version: 4
Effective Time: 20200525
 
Sinbad Co.,Ltd